A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
8. oktober 2010 oppdatert av: Pfizer
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
106
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Duarte, California, Forente stater, 91010-3000
- Pfizer Investigational Site
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Pasadena, California, Forente stater, 91105
- Pfizer Investigational Site
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San Francisco, California, Forente stater, 94115
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Pfizer Investigational Site
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Boston, Massachusetts, Forente stater, 02115
- Pfizer Investigational Site
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Boston, Massachusetts, Forente stater, 02215
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Pfizer Investigational Site
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Pfizer Investigational Site
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New York
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New York, New York, Forente stater, 10021
- Pfizer Investigational Site
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New York, New York, Forente stater, 10022
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Pfizer Investigational Site
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, Forente stater, 97213
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Pfizer Investigational Site
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- Pfizer Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Cytokine refractory metastatic renal cell carcinoma with clear cell component
- Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
- Prior nephrectomy
Exclusion Criteria:
- Prior treatment with any systemic therapy other than 1 cytokine therapy
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
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50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
Tidsramme: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST.
CR defined as disappearance of all target lesions.
PR defined as >= 30 percent 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 study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Tumor Progression (TTP)
Tidsramme: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first.
TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Duration of Response (DR)
Tidsramme: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of patients with a confirmed objective tumor response. |
Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Overall Survival (OS)
Tidsramme: From start of study treatment until death
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Time in weeks from the start of study treatment to date of death due to any cause.
OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).
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From start of study treatment until death
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Progression-free Survival (PFS)
Tidsramme: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause.
PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Percent Chance of Patient Survival
Tidsramme: From start of study treatment until death
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Probability of survival 1 year and 2 years after the first dose of study treatment
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From start of study treatment until death
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Observed Plasma Trough Concentrations of Sunitinib
Tidsramme: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Metabolite
Tidsramme: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Tidsramme: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib
Tidsramme: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib.
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Tidsramme: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Tidsramme: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
- Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2004
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. september 2008
Datoer for studieregistrering
Først innsendt
13. februar 2004
Først innsendt som oppfylte QC-kriteriene
17. februar 2004
Først lagt ut (Anslag)
18. februar 2004
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. oktober 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2010
Sist bekreftet
1. oktober 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Nyre-neoplasmer
- Karsinom, nyrecelle
- Karsinom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Sunitinib
Andre studie-ID-numre
- A6181006
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .