Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate
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|ClinicalTrials.gov Identifier: NCT01792687|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : February 12, 2021
|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|
|Actual Primary Completion Date :||May 10, 2014|
|Estimated Study Completion Date :||June 30, 2021|
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, daily
Drug: Abiraterone acetate
1,000 mg, oral, daily
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.
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): NCT01792687
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Study Director:||Aragon Pharmaceuticals, Inc Clinical Trial||Aragon Pharmaceuticals, Inc.|