Phase 2
N=127
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01171898 ↗Enrolled (actual)
127
Serious AEs
30.7%
Results posted
Jul 2018
Primary outcome: Primary: Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12 — 47; 89; 88; 22 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ARN-509 (Phase 1) (Drug); ARN-509 (Phase 2) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Aragon Pharmaceuticals, Inc.
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12 |
47; 89; 88; 22 | — |
| SECONDARY Phase 1 and 2: Median Time to PSA Progression |
4.9; 24.0; 16.5; 3.0 | — |
| SECONDARY Phase 2: Median Metastasis-Free Survival (MFS) |
21.6 | — |
| SECONDARY Phase 1 and 2: Progression-free Survival (PFS) |
16.82; 36.37; NA | — |
| SECONDARY Phase 1 and 2: Objective Response Rate |
20; 0; 50; 0 | — |
Summary
The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.
Eligibility Criteria
NON-METASTATIC CRPC
Inclusion Criteria
- Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value >=8 ng/mL within the last 3 months or PSA Doubling Time 450 msec
- History of seizure or condition that may predispose to seizure
- Evidence of severe or uncontrolled systemic disease or HIV infection
METASTATIC CRPC, TREATMENT-NAIVE
Inclusion Criteria
- Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
- Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
- Castrate levels of serum testosterone of less than or equal to 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- A life expectancy of at least 3 months
Exclusion Criteria
- History of, or current metastases in the brain or untreated spinal cord compression
- Prior treatment with MDV3100
- Prior treatment with abiraterone
- Prior treatment with ketoconazole
- Concurrent treatment with medications known to have seizure potential
- Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
- QTc > 450 msec
- History of seizure or condition that may predispose to seizure
- Evidence of severe or uncontrolled systemic disease or HIV infection
METASTATIC CRPC, CHEMOTHERAPY-NAIVE, POST-ABIRATERONE
Inclusion Criteria
- Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
- Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
- Castrate levels of serum testosterone of less than or equal to 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- A life expectancy of at least 3 months
- Patients must have received a minimum of 6 months of abiraterone treatment prior to disease progression
Exclusion Criteria
- History of, or current metastases in the brain or untreated spinal cord compression
- Prior treatment with MDV3100
- Prior treatment with ketoconazole
- Concurrent treatment with medications known to have seizure potential
- Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
- QTc > 450 msec
- History of seizure or condition that may predispose to seizure
- Evidence of severe or uncontrolled systemic disease or HIV infection
Data sourced from ClinicalTrials.gov (NCT01171898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.