A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
- Conditions
- metastatic prostate cancer10036958
- Registration Number
- NL-OMON54643
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
1. Histologically confirmed metastatic prostate cancer with no prior systemic
therapy in the
mCRPC setting
2. Can provide blood sample for determination of HRR
3. Willing to provide a fresh or archival tumor tissue sample for determination
of HRR
4. HRR status (as identified by the sponsor*s required assays or positive BRCA1
or BRCA2 germline testing results from certified laboratories as acceptable for
screening.) as follows:
a. Cohort 1: positive for HRR (per protocol amendment 3: stop enrollment of
subjects with ATM mutations into Cohort 1 and to ensure at least 50% of Cohort
1 are subjects with BRCA mutations)
b. Cohort 2: not positive for HRR (ie, no HRR)
c. Cohort 3: positive or not positive for HRR gene alterations
5. Must be able to continue GnRHa during the study if not surgically castrate
6. ECOG PS grade of 0 or 1
7. Adequate hematologic and metabolic values at screening
1. Prior treatment with a PARP inhibitor
2.Systemic therapy in the mCRPC setting; or AA-P outside of the mCRPC setting.
3.For subjects who received 2 to 4 months of AA-P prior to randomization for
the treatment of mCRPC, evidence of progression by PSA (per PCWG3) during
screening.
4.. Severe or unstable angina, myocardial infarction, symptomatic congestive
heart failure,
arterial or venous thromboembolic events (e.g, pulmonary embolism,
cerebrovascular
accident including transient ischemic attacks), or clinically significant
ventricular
arrhythmias within 6 months prior to randomization or New York Heart Association
(NYHA) Class II to IV heart disease.
5.. Presence of uncontrolled hypertension (systolic blood pressure [BP] >160
mmHg or
diastolic BP >100 mmHg). Subjects with a history of hypertension are allowed,
provided
that BP is controlled to within these limits by anti-hypertensive treatment.
6. Active or symptomatic viral hepatitis or chronic liver disease (as evidenced
by ascites or
bleeding disorders secondary to hepatic dysfunction)
7. Subjects who have had the following <=30 days prior to planned Cycle 1 Day 1:
a. a transfusion (platelets or red blood cells)
b. hematopoietic growth factors
c. an investigational agent for prostate cancer
d. major surgery
e. radiation therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Radiographic progression-free survival (rPFS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Overall Survival<br /><br>-Time-to-symptomatic progression<br /><br>-Time to initiation of cytotoxic chemotherapy<br /><br>-Observed plasma concentrations of niraparib<br /><br>and abiraterone and estimated population PK<br /><br>and exposure parameters for niraparib<br /><br>-Incidence and severity of AEs<br /><br>-Clinical laboratory test results</p><br>