AMG 208 Tumor Microenvironment in Metastatic Castration Resistant Prostate Cancer (mCRPC)
|ClinicalTrials.gov Identifier: NCT02420587|
Recruitment Status : Withdrawn
First Posted : April 20, 2015
Last Update Posted : April 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: AMG 208 Behavioral: Questionnaire||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of AMG 208 Evaluating the Tumor Microenvironment in Metastatic Castration-Resistant Prostate Cancer|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2019|
Experimental: AMG 208
Dose of AMG 208 is 400 mg by mouth daily given in 6 weeks cycles. Participants receive AMG 208 until radiographic progression of disease and/or unequivocal clinical progression. Questionnaire completion about pain at baseline, Day 22 of Cycle 1, Day 1 of Cycle 2, Day 22 of Cycle 2, every 6 weeks, and at end of study visit.
Drug: AMG 208
Dose of AMG 208 is 400 mg by mouth daily given in 6 weeks cycles.
Questionnaire completion about pain at baseline, Day 22 of Cycle 1, Day 1 of Cycle 2, Day 22 of Cycle 2, every 6 weeks, and at end of study visit.
Other Name: Survey
- Progression-Free Survival (PFS) [ Time Frame: 6 weeks ]Progression free survival (PFS) defined as the time from treatment start to the time of clinical progression or death, whichever occurs first, or the time of last contact. The primary efficacy endpoint, PFS, continuously monitored using the Bayesian method by Thall et al.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420587
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amado Zurita, MD||M.D. Anderson Cancer Center|