- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00642018
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
11 marzo 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
154
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Augsburg, Germania, 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, Germania, 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, Germania, 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, Germania, 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, Germania, 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, Germania, 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, Germania, 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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Gdansk, Polonia, 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, Polonia, 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, Polonia, 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, Polonia, 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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Barcelona, Spagna, 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, Spagna, 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, Spagna, 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, Spagna, 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, Spagna, 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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Tennessee
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Memphis, Tennessee, Stati Uniti, 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Adverse Event Profile
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
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Numero di partecipanti deceduti a causa di malattia progressiva durante i 30 giorni successivi all'interruzione del trattamento in studio
Lasso di tempo: Interruzione del trattamento in studio fino a 30 giorni dopo l'interruzione del trattamento in studio
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Interruzione del trattamento in studio fino a 30 giorni dopo l'interruzione del trattamento in studio
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: 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
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2008
Completamento primario (Effettivo)
1 agosto 2011
Completamento dello studio (Effettivo)
1 aprile 2012
Date di iscrizione allo studio
Primo inviato
28 febbraio 2008
Primo inviato che soddisfa i criteri di controllo qualità
19 marzo 2008
Primo Inserito (Stima)
24 marzo 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 marzo 2019
Ultimo verificato
1 marzo 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie genitali, maschio
- Malattie della prostata
- Neoplasie prostatiche
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfiammatori
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Docetaxel
- Prednisone
Altri numeri di identificazione dello studio
- 10461
- H8Z-MC-JACR (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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