Phase 1b Study of ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate

NCT02106507 Phase 1 COMPLETED

The purpose of this study is to test the safety of the combination of apalutamide plus everolimus at different dose levels.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	COMPLETED
Enrolment	9
Start date	2014-04
Completion	2021-06-28

Conditions

• Prostate Cancer

Interventions

• apalutamide
• Everolimus

Primary outcomes

• safety — 2 years
  Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events V4.0 (CTCAE). Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests throughout the conduct of the study.
• pharmacokinetics — 2 years
  Pharmacokinetic parameters (Cmax, Tmax, AUC(INF), AUC(TAU), will be derived from blood to obtain everolimus concentration or plasma to obtain apalutamide and it's major metabolite concentration versus time data for patients in the dose escalation cohorts.
• maximum tolerated dose (MTD) — 2 years
  The first phase of the study will examine the safety of apalutamide in combination with everolimus in patients with metastatic castration-resistant prostate cancer. Up to 2 dose levels will be tested. A standard "3 plus 3" dose escalation rule will be used in order to determine the MTD/RP2D. Patients will be treated in cohorts of three and the dosage will be escalated if the clinical toxicity is acceptable. The MTD is defined as the highest dose with an observed incidence of dose limiting toxicity (DLT) in no more than one out of six patients treated at a particular dose level.

Countries

United States