- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00642018
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
maanantai 11. maaliskuuta 2019 päivittänyt: Eli Lilly and Company
A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer
The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
154
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Barcelona, Espanja, 08036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Benidorm, Espanja, 03501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Elda, Espanja, 03600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Espanja, 28050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pamplona, Espanja, 31008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gdansk, Puola, 80-219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kielce, Puola, 25-734
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Olsztyn, Puola, 10-228
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Warsaw, Puola, 02-781
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Augsburg, Saksa, 86150
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Frankfurt, Saksa, 60488
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hannover, Saksa, 30625
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Heidelberg, Saksa, 69115
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Heilbronn, Saksa, D-74078
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Homburg, Saksa, 66421
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Muenchen-Planegg, Saksa, 82152
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Memphis, Tennessee, Yhdysvallat, 38138
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 - 75 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Uros
Kuvaus
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable
- Hormone refractory prostate cancer defined as progressive based by documented 2 increase Prostate specific antigen (PSA) values over a previous reference value.
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Adequate hematological functions, liver and renal functions
Exclusion Criteria:
- Known hypersensitivity to docetaxel or taxane therapy
- Documented central nervous system or leptomeningeal metastasis at time of study entry
- Had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.
- Evidence of painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionuclides are necessary.
- Have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.
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: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: A: Docetaxel
Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy
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Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle.
Patients may receive up to 10 cycles of study therapy or until progressive disease.
Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
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Kokeellinen: B: LY2181308 + Docetaxel
LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
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Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle.
Patients may receive up to 10 cycles of study therapy or until progressive disease.
Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days.
Patients may receive up to 10 cycles of study therapy or until progressive disease.
Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
Aikaikkuna: Baseline to measured progressive disease or death due to any cause up to 44.68 months
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PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause.
PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
For participants who had no PD or death, PFS was censored at their last contact.
Participants were still followed for PFS after they stopped receiving study drug.
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Baseline to measured progressive disease or death due to any cause up to 44.68 months
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Number of Participants With Adverse Events (Safety)
Aikaikkuna: First treatment dose up to 19 months
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Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period.
A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.
The participants received maximum 24 cycles of treatment (1cycle = 3 weeks).
Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
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First treatment dose up to 19 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Adverse Event Profile
Aikaikkuna: First treatment dose up to 19 months
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Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug.
The participants received maximum 24 cycles of treatment (1cycle = 3 weeks).
Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
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First treatment dose up to 19 months
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Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)
Aikaikkuna: Predose up to 8 hours postdose in Cycle 1
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Predose up to 8 hours postdose in Cycle 1
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Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)
Aikaikkuna: Baseline, 18 months
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PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value.
Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated.
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Baseline, 18 months
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Estimate Overall Survival
Aikaikkuna: First treatment to death due to any cause up to 45.54 months
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Overall survival is defined as the time from date of first treatment to the date of death due to any cause.
For participants who were alive, overall survival was censored at their last contact.
Participants were still followed for overall survival after they stopped receiving study drug.
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First treatment to death due to any cause up to 45.54 months
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Estimate Duration of Overall Response
Aikaikkuna: Time of response to time of measured progressive disease up to 41.00 months
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The duration of response [complete response (CR) or partial response (PR)] was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines.
CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
For participants who had no progression or death, the duration of response was censored at their last contact.
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Time of response to time of measured progressive disease up to 41.00 months
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Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)
Aikaikkuna: Baseline to measured progressive disease up to 41.00 months
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Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
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Baseline to measured progressive disease up to 41.00 months
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Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)
Aikaikkuna: Baseline, 21 days
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G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline.
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Baseline, 21 days
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Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)
Aikaikkuna: 3 months
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The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items).
All items are scored from 0 (not at all) to 4 (very much).
The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms.
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3 months
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Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)
Aikaikkuna: 3 months
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The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items).
All items are scored from 0 (not at all) to 4 (very much).
The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms.
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3 months
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Muut tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Progressiiviseen sairauteen kuolleiden osallistujien määrä 30 päivän aikana tutkimushoidon lopettamisen jälkeen
Aikaikkuna: Tutkimushoidon keskeyttäminen enintään 30 päivää tutkimushoidon lopettamisen jälkeen
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Tutkimushoidon keskeyttäminen enintään 30 päivää tutkimushoidon lopettamisen jälkeen
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST), Eli Lilly and Company
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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
Lauantai 1. maaliskuuta 2008
Ensisijainen valmistuminen (Todellinen)
Maanantai 1. elokuuta 2011
Opintojen valmistuminen (Todellinen)
Sunnuntai 1. huhtikuuta 2012
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 28. helmikuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 19. maaliskuuta 2008
Ensimmäinen Lähetetty (Arvio)
Maanantai 24. maaliskuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 3. huhtikuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 11. maaliskuuta 2019
Viimeksi vahvistettu
Perjantai 1. maaliskuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Sukuelinten kasvaimet, mies
- Eturauhasen sairaudet
- Eturauhasen kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Tulehdusta ehkäisevät aineet
- Antineoplastiset aineet
- Tubuliinimodulaattorit
- Antimitoottiset aineet
- Mitoosin modulaattorit
- Glukokortikoidit
- Hormonit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Antineoplastiset aineet, hormonaaliset
- Doketakseli
- Prednisoni
Muut tutkimustunnusnumerot
- 10461
- H8Z-MC-JACR (Muu tunniste: Eli Lilly and Company)
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 .
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