- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00113516
A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
perjantai 14. toukokuuta 2010 päivittänyt: Pfizer
Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
84
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z4E6
- Pfizer Investigational Site
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Quebec
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Montreal, Quebec, Kanada, H2L 4M1
- Pfizer Investigational Site
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Caen Cedex 05, Ranska, 14076
- Pfizer Investigational Site
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Villejuif, Ranska, 94805
- Pfizer Investigational Site
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California
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Los Angeles, California, Yhdysvallat, 90048
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, Yhdysvallat, 19718
- Pfizer Investigational Site
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Newark, Delaware, Yhdysvallat, 19713
- Pfizer Investigational Site
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Wilmington, Delaware, Yhdysvallat, 19899
- Pfizer Investigational Site
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Illinois
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Maywood, Illinois, Yhdysvallat, 60153
- Pfizer Investigational Site
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Indiana
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Jeffersonville, Indiana, Yhdysvallat, 47130
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40202
- Pfizer Investigational Site
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Louisville, Kentucky, Yhdysvallat, 40217
- Pfizer Investigational Site
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Louisville, Kentucky, Yhdysvallat, 40241
- Pfizer Investigational Site
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Shelbyville, Kentucky, Yhdysvallat, 40065
- Pfizer Investigational Site
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Pennsylvania
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Hershey, Pennsylvania, Yhdysvallat, 17033
- Pfizer Investigational Site
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Tennessee
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Franklin, Tennessee, Yhdysvallat, 37067
- Pfizer Investigational Site
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Gallatin, Tennessee, Yhdysvallat, 37066
- Pfizer Investigational Site
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Hermitage, Tennessee, Yhdysvallat, 37076
- Pfizer Investigational Site
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Lebanon, Tennessee, Yhdysvallat, 37087
- Pfizer Investigational Site
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Murfreesboro, Tennessee, Yhdysvallat, 37130
- Pfizer Investigational Site
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Nashville, Tennessee, Yhdysvallat, 37203
- Pfizer Investigational Site
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Nashville, Tennessee, Yhdysvallat, 37205
- Pfizer Investigational Site
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Nashville, Tennessee, Yhdysvallat, 37207
- Pfizer Investigational Site
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Nashville, Tennessee, Yhdysvallat, 37211
- Pfizer Investigational Site
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Nashville, Tennessee, Yhdysvallat, 37203-1632
- Pfizer Investigational Site
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Smyrna, Tennessee, Yhdysvallat, 37167
- Pfizer Investigational Site
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Texas
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Burleson, Texas, Yhdysvallat, 76028
- Pfizer Investigational Site
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Cleburne, Texas, Yhdysvallat, 76031
- Pfizer Investigational Site
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Fort Worth, Texas, Yhdysvallat, 76104
- Pfizer Investigational Site
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Mineral Wells, Texas, Yhdysvallat, 76067
- Pfizer Investigational Site
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Weatherford, Texas, Yhdysvallat, 76086
- Pfizer Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Histologically proven NSCLC
- Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
- No prior therapy for NSCLC
- Evidence of unidimensionally measurable disease
Exclusion Criteria:
- Previous treatment with systemic chemotherapy for lung cancer
- History of or known brain metastases
- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
- Evidence of hemoptysis within 4 weeks of starting study treatment
- Serious acute or chronic illness or recent history of significant cardiac abnormality
- Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 1
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AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
Muut nimet:
175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
Muut nimet:
50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Proportion of Subjects Surviving at One Year
Aikaikkuna: From start of treatment until 1 year or death
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Proportion of those surviving at the end of one year from the first dose of study treatment.
In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive.
Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.
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From start of treatment until 1 year or death
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Progression-free Survival (PFS)
Aikaikkuna: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
|
PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.
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From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
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Time to Tumor Progression (TTP)
Aikaikkuna: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
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TTP was defined as the time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.
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From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
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Duration of Response (DR)
Aikaikkuna: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
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DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first.
CR=disappearance of all target lesions.
PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
If tumor progression data included more than 1 date, first date was used.
DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02.
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From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
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Number of Subjects With Overall Confirmed Objective Disease Response
Aikaikkuna: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
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Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0).
A CR was defined as the disappearance of all target lesions.
A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
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Overall Survival (OS)
Aikaikkuna: From start of study treatment until death
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OS was defined as the time from start of study treatment to death due to any cause.
OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.
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From start of study treatment until death
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Trough Plasma Concentration (Ctrough) of Sunitinib
Aikaikkuna: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough of SU-012662 (Sunitinib's Metabolite)
Aikaikkuna: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough of Total Drug (Sunitinib + SU-012662)
Aikaikkuna: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
|
Ctrough = the plasma concentration prior to study drug administration.
On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Dose-Corrected Ctrough of Sunitinib
Aikaikkuna: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
Dose correction was made to the initial intended dose in Cycle 1.
This was determined due to potential dose changes throughout the study in different subjects.
It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose.
For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Aikaikkuna: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
|
Ctrough = the plasma concentration prior to study drug administration.
Dose correction was made to the initial intended dose in Cycle 1.
This was determined due to potential dose changes throughout the study in different subjects.
It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose.
For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
|
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Aikaikkuna: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
|
Ctrough = the plasma concentration prior to study drug administration.
Dose correction was made to the initial intended dose in Cycle 1.
This was determined due to potential dose changes throughout the study in different subjects.
It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose.
For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline
Aikaikkuna: Baseline (Cycle 1, Day 1) of Part 2
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Concentration of VEGFR3 at baseline.
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Baseline (Cycle 1, Day 1) of Part 2
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VEGFR3 Ratio to Baseline at Each Time Point
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGF-C Concentration at Baseline
Aikaikkuna: Baseline (Cycle 1, Day 1) of Part 2
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Concentration of VEGF-C at baseline.
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Baseline (Cycle 1, Day 1) of Part 2
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VEGF-C Ratio to Baseline at Each Time Point
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Soluble E-Selectin at Baseline
Aikaikkuna: Baseline (Cycle 1, Day 1) of Part 2
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Concentration of soluble E-Selectin at baseline.
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Baseline (Cycle 1, Day 1) of Part 2
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Soluble E-Selectin Ratio to Baseline at Each Time Point
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
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Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
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VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Aikaikkuna: Baseline (Cycle 1, Day 1) of Part 2
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Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) of Part 2
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VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Aikaikkuna: Baseline (Cycle 1, Day 1) of Part 2
|
Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) of Part 2
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VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Aikaikkuna: Baseline (Cycle 1, Day 1) of Part 2
|
Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
|
Baseline (Cycle 1, Day 1) of Part 2
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Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
|
Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02.
Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
Aikaikkuna: [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
|
PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.
|
[Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
TTP = time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
TTP = time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
|
TTP = time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
|
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
OS = time from start of study treatment to death due to any cause.
OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment.
Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
OS = time from start of study treatment to death due to any cause.
OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment.
Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
|
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
Aikaikkuna: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
|
OS=time from start of study treatment to death due to any cause.
OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4.
For subjects not expiring their survival times were censored at last date of known contact they were known to be alive.
Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment.
Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.
|
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
|
Immunohistochemical Staining of Paraffin Embedded Tumor Tissue
Aikaikkuna: Screening
|
Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.
|
Screening
|
Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib
Aikaikkuna: Within 7 days of Day 1
|
A blood sample (6 mL) was collected and used to isolate DNA.
These samples were not anonymized.
|
Within 7 days of Day 1
|
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Aikaikkuna: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
|
EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea).
Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent.
Scale score range: 0 to 100.
Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Change: score at each visit in Part 2 minus baseline score in Part 1.
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Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)
Aikaikkuna: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts).
Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100.
Higher symptom score = greater degree of symptoms.
Change: score at each visit in Part 2 minus baseline score in Part 1.
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Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Torstai 1. syyskuuta 2005
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. maaliskuuta 2009
Opintojen valmistuminen (Todellinen)
Sunnuntai 1. maaliskuuta 2009
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 8. kesäkuuta 2005
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 8. kesäkuuta 2005
Ensimmäinen Lähetetty (Arvio)
Torstai 9. kesäkuuta 2005
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Tiistai 18. toukokuuta 2010
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 14. toukokuuta 2010
Viimeksi vahvistettu
Lauantai 1. toukokuuta 2010
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Neoplasmat
- Keuhkosairaudet
- Neoplasmat sivustoittain
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Keuhkojen kasvaimet
- Karsinooma, ei-pienisoluinen keuhko
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Entsyymin estäjät
- Antineoplastiset aineet
- Tubuliinimodulaattorit
- Antimitoottiset aineet
- Mitoosin modulaattorit
- Antineoplastiset aineet, fytogeeniset
- Angiogeneesin estäjät
- Angiogeneesiä moduloivat aineet
- Kasvuaineet
- Kasvun estäjät
- Proteiinikinaasin estäjät
- Karboplatiini
- Paklitakseli
- Sunitinib
Muut tutkimustunnusnumerot
- A6181057
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Ei-pienisoluinen keuhkosyöpä
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Jonsson Comprehensive Cancer CenterEli Lilly and Company; Genentech, Inc.RekrytointiMetastaattinen keuhkojen ei-pienisolusyöpä | Tulenkestävä keuhkojen ei-pienisolusyöpä | Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8 | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8Yhdysvallat
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University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Keuhkojen ei-pienisolukarsinooma | Vaiheen III keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Vaiheen II keuhkosyöpä AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Vaiheen IIB keuhkosyöpä AJCC v8 | Vaiheen IIIA keuhkosyöpä AJCC v8 | Vaiheen IIIB... ja muut ehdotYhdysvallat
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Eben RosenthalRekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Keuhkokarsinooma | Metastaattinen pahanlaatuinen kasvain keuhkoissaYhdysvallat
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Wake Forest University Health SciencesNational Cancer Institute (NCI)LopetettuPienisoluinen keuhkosyöpä | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8Yhdysvallat
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Emory UniversityNational Cancer Institute (NCI)RekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Keuhkojen ei-pienisolukarsinooma | IV vaiheen keuhkosyöpä AJCC v8Yhdysvallat
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; California Institute... ja muut yhteistyökumppanitAktiivinen, ei rekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Keuhkojen ei-pienisolukarsinooma | IV vaiheen keuhkosyöpä AJCC v8Yhdysvallat
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Ohio State University Comprehensive Cancer CenterRekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Keuhkojen ei-squamous ei-pienisolusyöpä | Vaiheen IIIB keuhkosyöpä AJCC v8Yhdysvallat
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Vaiheen III keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Vaiheen II keuhkosyöpä AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Vaiheen IIB keuhkosyöpä AJCC v8 | Vaiheen IIIA keuhkosyöpä AJCC v8 | Vaiheen IIIB keuhkosyöpä AJCC v8 | I vaiheen... ja muut ehdotYhdysvallat
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M.D. Anderson Cancer CenterPeruutettuMetastaattinen keuhkojen ei-pienisolusyöpä | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RekrytointiMetastaattinen keuhkojen ei-pienisolusyöpä | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Vaiheen III keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Vaiheen II keuhkosyöpä AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Vaiheen IIB keuhkosyöpä AJCC v8 | Vaiheen IIIA keuhkosyöpä AJCC v8 | Vaiheen... ja muut ehdotYhdysvallat
Kliiniset tutkimukset carboplatin
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Instituto Nacional de Cancerologia de MexicoRekrytointiKeuhkosyöpä | Sarkopenia | MyrkyllisyysMeksiko
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James ElderValmisAikuisten anaplastinen astrosytooma | Aikuisten anaplastinen oligodendrogliooma | Toistuva aikuisen aivokasvainYhdysvallat
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Wake Forest University Health SciencesNational Cancer Institute (NCI)ValmisToistuva ei-pienisoluinen keuhkosyöpä | IV vaiheen ei-pienisoluinen keuhkosyöpäYhdysvallat
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Northwestern UniversityEisai Inc.TuntematonMiehen rintasyöpä | Vaiheen II rintasyöpä | Vaiheen IIIA rintasyöpä | Vaiheen IIIB rintasyöpä | Kolminkertaisesti negatiivinen rintasyöpä | Vaiheen IA rintasyöpä | Vaiheen IB rintasyöpä | Vaiheen IIIC rintasyöpä | Estrogeenireseptori-negatiivinen rintasyöpä | Progesteronireseptorinegatiivinen rintasyöpä | HER2-negatiivinen...Yhdysvallat
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National Cancer Institute (NCI)Gynecologic Oncology GroupValmisMunajohtimien syöpä | Munasarjan kirkassoluinen kystadenokarsinooma | Munasarjan endometrioidinen adenokarsinooma | Munasarjan seroosi kystadenokarsinooma | Ensisijainen vatsaontelon syöpä | Brennerin kasvain | Toistuva munasarjan epiteelisyöpä | Munasarjojen limakalvokystadenokarsinooma | Munasarjojen sekaepiteelisyövä ja muut ehdotYhdysvallat
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Heath SkinnerRekrytointi
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Shanghai General Hospital, Shanghai Jiao Tong University...TuntematonKastraatioresistentti eturauhassyöpä
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National Cancer Institute (NCI)ValmisMäärittelemätön aikuisen kiinteä kasvain, protokollakohtainenYhdysvallat
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Jonsson Comprehensive Cancer CenterTetraLogic Pharmaceuticals; California Institute for Regenerative Medicine... ja muut yhteistyökumppanitPeruutettuToistuva munanjohtimien karsinooma | Toistuva munasarjasyöpä | Toistuva primaarinen peritoneaalinen syöpä | Ensisijainen vatsakalvon korkea-asteinen seroottinen adenokarsinooma | Korkea-asteinen munasarjojen seroosi adenokarsinooma | Korkea-asteinen munanjohtimien seroottinen adenokarsinoomaYhdysvallat
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Valmis