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Prostate

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Unique Data Set IDProstat_Millenn_2010_165
DownloadableYes
SponsorMillennium Pharmaceuticals, Inc.Data ProviderMillennium, the Takeda Oncology CompanyTotal Study Enrolled Patients1560Comparator (Control) Arm Enrolled Patients781RandomizationYesClinicalTrial.gov IDNCT01193244ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/study/NCT01193244
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeHormonesData Set TypeADS

Clinical Trial Title

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Trial Summary and Conditions

Study 21004 was a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy naive, metastatic, castration-resistant prostate cancer (mCRPC). Patients in the 2 treatment groups received blinded study drug (orteronel or placebo) twice daily through the study in addition to open-label prednisone and gonadotropin-releasing hormone (GnRH) analogue therapy. Patients who had undergone orchiectomy and had a testosterone concentration of <50 ng/dL could have participated in the study without prior or ongoing concomitant GnRH analogue treatment. One formal interim analysis was planned for this study after approximately 412 radiographic disease progression events were observed. The final analysis was to be conducted after approximately 600 overall survival (OS) events occurred. If the study met at least 1 of the co-primary endpoints at the final analysis, patients who were receiving placebo were allowed to cross over to orteronel treatment. The study was expected to last approximately 45 months until reaching the final analysis of the OS endpoint. Patients were followed for survival until 80% of patients died or were lost to follow-up. Randomization was in a 1:1 ratio, stratified by region (North America [US and Canada], Europe, and rest of world) and radiographic disease progression at baseline (Yes/No).

Data Summary

Control arm data files include raw data on safety, efficacy, demographic, and baseline disease characteristics.

Study Objectives

The primary objectives of this study were to determine if orteronel plus prednisone improved radiographic progression-free survival (rPFS) and to determine if orteronel plus prednisone improved overall survival (OS). The key secondary objectives were: to determine if orteronel plus prednisone improved 50% prostate-specific antigen (PSA) response at 12 weeks, to evaluate changes in circulating tumor cell (CTC) counts, and to evaluate whether orteronel improved time to pain progression. The safety objectives included the incidence of treatment-emergent adverse events (AEs), severity and type of AEs, and by changes from baseline in the patient's vital signs, weight, Eastern Cooperative Oncology Group performance status, electrocardiogram, cardiac ejection fraction test results, dual energy X-ray absorptiometry, and clinical laboratory results.

Outcome Measures

The primary endpoints of this study were rPFS, defined as time from randomization to radiographic disease progression or death from any cause, whichever occurred first, and OS. Secondary efficacy endpoints included: 50% prostate-specific antigen (PSA) response at 12 weeks, favorable changes in CTC levels at 12 weeks, and time to pain progression as measured by worst pain item in the Brief Pain Inventory-Short Form (BPI-SF) and changes in opioid analgesic use, if any.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Millennium_TAK-700_C21004_Protocol.pdf

CRF: Millennium_TAK-700_C21004_CRFs.pdf

DATA DICTIONARY: Millennium_C21004_ADAM_spec.xls

DATA (COMPARATOR ARM): Millennium_C21004_Analysis_Data.tar.zip

DATA (COMPARATOR ARM): Millennium_C21004_Raw_Data.tar.zip