- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00642018
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
11. mars 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
154
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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Tennessee
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Memphis, Tennessee, Forente stater, 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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Gdansk, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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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Augsburg, Tyskland, 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, Tyskland, 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, Tyskland, 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, Tyskland, 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, Tyskland, 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, Tyskland, 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, Tyskland, 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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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 til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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.
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Adverse Event Profile
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tidsramme |
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Antall deltakere som døde på grunn av progressiv sykdom i løpet av de 30 dagene etter seponering fra studiebehandling
Tidsramme: Seponering av studiebehandling inntil 30 dager etter seponering av studiebehandling
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Seponering av studiebehandling inntil 30 dager etter seponering av studiebehandling
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: 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
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.
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. mars 2008
Primær fullføring (Faktiske)
1. august 2011
Studiet fullført (Faktiske)
1. april 2012
Datoer for studieregistrering
Først innsendt
28. februar 2008
Først innsendt som oppfylte QC-kriteriene
19. mars 2008
Først lagt ut (Anslag)
24. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Genitale neoplasmer, hanner
- Prostata sykdommer
- Prostatiske neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Docetaxel
- Prednison
Andre studie-ID-numre
- 10461
- H8Z-MC-JACR (Annen identifikator: Eli Lilly and Company)
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. .
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