Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate
|ClinicalTrials.gov Identifier: NCT01792687|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: ARN-509 Drug: Abiraterone acetate Drug: Prednisone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN-509 in Combination With Abiraterone Acetate in Patients With Metastatic Castrate Resistant Prostate Cancer (CRPC)|
|Actual Study Start Date :||February 5, 2013|
|Primary Completion Date :||May 10, 2014|
|Estimated Study Completion Date :||December 11, 2018|
ARN-509 when combined with the approved dose of abiraterone acetate (1,000 mg daily) plus prednisone (5 mg daily).
Dose-escalation: 120 milligram (mg), 180 mg, 240 mg, oral, dailyDrug: Abiraterone acetate
1,000 mg, oral, dailyDrug: Prednisone
5 mg, oral, daily
- Maximum Tolerated Dose (MTD) / Recommended Phase 2 dosage (RP2D) [ Time Frame: 12 months ]To determine the Maximum Tolerated Dosage (MTD)/ Recommended Phase 2 dosage (RP2D) of ARN-509 when administered in combination with abiraterone acetate.
- Pharmacokinetics [ Time Frame: 12 months ]To characterize the pharmacokinetics (PK) of abiraterone at steady-state prior to ARN-509 administration, and both abiraterone and ARN-509 at steady-state following combined dosing of both agents.
- Anti-tumor activity [ Time Frame: 12 months ]To perform preliminary assessment of the anti-tumor activity of ARN 509 in combination with abiraterone acetate by evaluation of radiographic tumor response by modified RECIST criteria.
- PSA Response [ Time Frame: 12 months ]To assess the magnitude and duration of PSA response in patients receiving ARN 509 plus abiraterone acetate.
- Treatment Response/Resistance [ Time Frame: 12 months ]To analyze potential mechanisms of response and resistance to treatment with ARN-509 plus abiraterone acetate in tissue obtained from serial biopsies of CRPC.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792687
|United States, California|
|San Francisco, California, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Study Director:||Aragon Pharmaceuticals, Inc Clinical Trial||Aragon Pharmaceuticals, Inc.|