A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
11. března 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
154
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Augsburg, Německo, 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.
-
Frankfurt, Německo, 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.
-
Hannover, Německo, 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.
-
Heidelberg, Německo, 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.
-
Heilbronn, Německo, 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.
-
Homburg, Německo, 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.
-
Muenchen-Planegg, Německo, 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.
-
-
-
-
-
Gdansk, Polsko, 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.
-
Kielce, Polsko, 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.
-
Olsztyn, Polsko, 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.
-
Warsaw, Polsko, 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.
-
-
-
-
Tennessee
-
Memphis, Tennessee, Spojené státy, 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.
-
-
-
-
-
Barcelona, Španělsko, 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.
-
Benidorm, Španělsko, 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.
-
Elda, Španělsko, 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.
-
Madrid, Španělsko, 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.
-
Pamplona, Španělsko, 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.
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
|
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
|
|
Experimentální: 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
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
Časové okno: Baseline to measured progressive disease or death due to any cause up to 44.68 months
|
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.
|
Baseline to measured progressive disease or death due to any cause up to 44.68 months
|
|
Number of Participants With Adverse Events (Safety)
Časové okno: First treatment dose up to 19 months
|
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.
|
First treatment dose up to 19 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adverse Event Profile
Časové okno: First treatment dose up to 19 months
|
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.
|
First treatment dose up to 19 months
|
|
Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)
Časové okno: Predose up to 8 hours postdose in Cycle 1
|
Predose up to 8 hours postdose in Cycle 1
|
|
|
Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)
Časové okno: Baseline, 18 months
|
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.
|
Baseline, 18 months
|
|
Estimate Overall Survival
Časové okno: First treatment to death due to any cause up to 45.54 months
|
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.
|
First treatment to death due to any cause up to 45.54 months
|
|
Estimate Duration of Overall Response
Časové okno: Time of response to time of measured progressive disease up to 41.00 months
|
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.
|
Time of response to time of measured progressive disease up to 41.00 months
|
|
Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)
Časové okno: Baseline to measured progressive disease up to 41.00 months
|
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.
|
Baseline to measured progressive disease up to 41.00 months
|
|
Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)
Časové okno: Baseline, 21 days
|
G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline.
|
Baseline, 21 days
|
|
Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)
Časové okno: 3 months
|
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.
|
3 months
|
|
Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)
Časové okno: 3 months
|
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.
|
3 months
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Počet účastníků, kteří zemřeli v důsledku progresivního onemocnění během 30 dnů po přerušení léčby ve studii
Časové okno: Ukončení studijní léčby do 30 dnů po ukončení studijní léčby
|
Ukončení studijní léčby do 30 dnů po ukončení studijní léčby
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: 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
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2008
Primární dokončení (Aktuální)
1. srpna 2011
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
28. února 2008
První předloženo, které splnilo kritéria kontroly kvality
19. března 2008
První zveřejněno (Odhad)
24. března 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. března 2019
Naposledy ověřeno
1. března 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Genitální novotvary, muži
- Onemocnění prostaty
- Novotvary prostaty
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Protizánětlivé látky
- Antineoplastická činidla
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Glukokortikoidy
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Antineoplastická činidla, Hormonální
- Docetaxel
- Prednison
Další identifikační čísla studie
- 10461
- H8Z-MC-JACR (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .