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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 Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Unique Data Set IDProstat_Millenn_2010_166
DownloadableYes
SponsorMillennium Pharmaceuticals, Inc.Data ProviderMillennium, the Takeda Oncology CompanyTotal Study Enrolled Patients1099Comparator (Control) Arm Enrolled Patients365RandomizationYesClinicalTrial.gov IDNCT01193257ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT01193257
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 Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Trial Summary and Conditions

Study 21005 was a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone, compared with placebo plus prednisone, in men with metastatic, castration-resistant prostate cancer (mCRPC). Patients were randomized to receive orteronel 200 mg tablets BID plus prednisone 5 mg BID or placebo tablets plus prednisone 5 mg BID in a 2:1 ratio, stratified by region (North America [US and Canada], Europe, rest of world) and Brief Pain Inventory-Short Form (BPI-SF) worst pain score at screening (4 vs >4). Each 28-day treatment cycle was composed of continuous twice-daily study drug plus prednisone, and continued until radiographic disease progression was documented. Gonadotropin-releasing hormone (GnRH) analogue therapy was continued unless the patient was surgically castrated. Patients were to have evidence of disease progression during or after receiving a total of 360 mg/m2 docetaxel within a 6-month period. Patients who were clearly intolerant to docetaxel or had progressive disease before receiving 360 mg/m2 were also eligible if they had received 225 mg/m2 of docetaxel within a 6-month period and met the other study entry criteria. Two formal interim analyses were planned for this study. Upon the recommendation of the independent data monitoring committee to unblind the study, patients who received placebo were allowed to crossover to orteronel treatment.

Data Summary

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

Study Objectives

The primary objective was to determine if orteronel plus prednisone improved OS. The key secondary objectives were to determine if orteronel plus prednisone improved radiographic progression-free survival (rPFS), to determine if orteronel plus prednisone improved 50% prostate-specific antigen (PSA) response at 12 weeks, and to evaluate if orteronel plus prednisone improved pain response at 12 weeks. Other secondary objectives were: to assess the safety of orteronel plus prednisone, to determine if orteronel plus prednisone improved 50% and 90% PSA response rates, to determine if orteronel plus prednisone improved time to PSA progression, to assess the relationship between changes in CTC counts and other clinical endpoints, such as OS and time to disease progression, to determine tumor response rate and duration of tumor response in patients with tumor lesions that were measurable by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria, to assess time to pain progression, best pain response, time to pain response, and duration of pain response, to assess change in global health status as measured by the patient-reported outcome (PRO) instrument the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and to collect blood orteronel concentration data for use in a future integrated PK analysis.

Outcome Measures

The primary endpoint was OS. The key secondary endpoints were: rPFS, 50% PSA response at 12 weeks, and pain response rate at 12 weeks. The other secondary endpoints were: adverse events, physical examinations, vital signs, weight, ECOG performance status, cardiac assessments, and clinical laboratory evaluations; 50% PSA response at any time during the study, 90% PSA response at 12 weeks and at any time during the study, and best PSA response at any time during the study; time to PSA progression; changes in CTC counts; changes in target lesions in patients with measurable tumors by RECIST 1.1 criteria; time to pain progression, time to pain response, best pain response, and duration of pain response; Health-related Quality-of-Life (HRQOL) response rate as measured by the 2-item global QOL index of the EORTC QLQ-C30; and population pharmacokinetics of orteronel using sparse sampling time points.

Available Downloads:

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

PROTOCOL: Millennium_TAK-700_C21005_Protocol.pdf

CRF: Millennium_TAK-700_C21005_CRFs.pdf

DATA DICTIONARY: Millennium_TAK-700_C21005_ADAM SPEC.xls

DATA (COMPARATOR ARM): Millennium_TAK-700_C21005_Analysis_Data.tar.zip

DATA (COMPARATOR ARM): Millennium_TAK-700_C21005_Raw_Data_and_specs.zip