A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer (ARMOR2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01709734|
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: galeterone||Phase 2|
This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and target patient population and Part 2 will be expansion of the dose and patient population selected in Part 1. For eligible patients, there will be an optional extension dosing following the completion of Part 1 or Part 2 of the trial.
Obtaining of informed consent and screening may be performed up to 28 days prior to enrollment. Each patient will be able to receive his specified regimen for 3 consecutive cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. Eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Dose Confirmation
Dose A - galeterone tablets once daily PO for three months + extension
Dose B - galeterone tablets once daily PO for three months + extension
Dose C - galeterone tablets once daily PO for three months + extension
Other Name: TOK-001
Experimental: Dose Expansion
Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
Other Name: TOK-001
- Confirmation of recommended dose and patient population for Part 2 of the study. [ Time Frame: 3 months ]Confirmation of recommended dose and patient population for Part 2 of the study.
- Assessment of efficacy by means of PSA response. [ Time Frame: 3 months ]Assessment of efficacy by means of PSA response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709734
Show 23 Study Locations
|Principal Investigator:||Bruce Montgomery, M.D.||University of Washington Seattle Cancer Care Alliance|
|Principal Investigator:||Mary Ellen Taplin, M.D.||Dana-Farber Cancer Institute|