Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer||Drug: orteronel Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase 2 Trial of TAK-700 (Orteronel) Without Prednisone for Metastatic Castration-Resistant Prostate Cancer|
- AR protein expression levels in CTCs [ Time Frame: Up to 4 weeks ]The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of PSA response.
- PSA response, defined as occurrence of PSA decline to greater than or equal to 50% from baseline [ Time Frame: At 12 weeks ]Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.
- Best PSA response [ Time Frame: Up to 24 weeks ]Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
- Absolute change in PSA [ Time Frame: Baseline to 24 weeks ]Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
- Overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and PCWG2 criteria [ Time Frame: Up to 3 years ]Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.
- Duration of response using RECIST version 1.1 and PCWG2 criteria [ Time Frame: Up to 3 years ]Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.
- Incidence of adverse events by NCI CTCAE version 4 [ Time Frame: 30 days ]All toxicities observed will be summarized with tables according to system, specific toxicity, grade, attribution, and time of onset.
|Actual Study Start Date:||October 25, 2013|
|Study Completion Date:||July 26, 2016|
|Primary Completion Date:||July 23, 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (orteronel)
Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: TAK-700Other: laboratory biomarker analysis
I. To assess the relationship between circulating tumor cell (CTC)-based androgen receptor (AR) expression level and >=-50% prostate-specific antigen (PSA) decline following 12 weeks of therapy with TAK-700 (orteronel).
I. To assess changes in PSA and CTC levels and time to PSA progression (best response, decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based treatment.
II. To assess measurable disease response and time to radiographic disease progression for castration-resistant prostate cancer (CRPC) with or without prior docetaxel-based treatment.
III. To explore relationships between endocrine and clinical responses.
IV. To confirm the safety of TAK-700 administered without prednisone in patients with metastatic CRPC.
OUTLINE: Patients receive orteronel orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866423
|United States, California|
|USC Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Mitchell Gross||University of Southern California|