ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02106507
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apalutamide — DRUG
    apalutamide, 240 mg/day, oral
  • Everolimus — DRUG
    5 mg/day of everolimus dose of everolimus will be escalated to 10 mg/day depending on the safety seen during dose escalation and steady-state trough drug levels as recommended

Study Details

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

Key Dates

Start date
Apr 30, 2014
Status verified
May 2023
Primary completion
Jun 28, 2021
Completion
Jun 28, 2021

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Progressive Metastatic Castration-Resistant Prostate Cancer
    This is a single-institution Phase 1b dose-escalation study in which eligible patients with progressive mCRPC will receive oral doses of apalutamide in combination with everolimus.

Primary Outcome Measure

safety [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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