A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Patients with Metastatic Prostate Cancer
- Conditions
- Metastatic Prostate CancerMedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003364-12-CZ
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 1000
1. DRD status (identified by the sponsor’s required assays)
2. Metastatic disease documented by radiographic imaging
4. Able to continue GnRHa during the study if not surgically castrate
5. ECOG PS Grade of 0 or 1
6 Score of =3 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours).
7. Adequate clinical laboratory values at Screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700
1. Prior treatment with a PARP inhibitor
2. No prior systemic therapy for mCRPC except for GnRHa and limited AA-P
4. Symptomatic brain metastases
5. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
6. Other prior malignancy =2 years prior to randomization, or malignancy that currently requires active systemic therapy
7. Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g. adequate cardiac function), or clinically significant ventricular arrhythmias within 6 months prior to randomization or New York Heart Association (NYHA) Class II to IV heart disease
8. Presence of uncontrolled hypertension
9. Current evidence of any of the following:
a. Any medical condition that would make prednisone use contraindicated
b. Any chronic medical condition requiring a higher equivalent dose of corticosteroid than 10 mg prednisone (or equivalent) per day
11. History of adrenal dysfunction
13. Subjects who are receiving opioid analgesics at the time of screening
14. Active human immunodeficiency virus (HIV) infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: * To assess the clinical benefit of niraparib plus AA-P compared to AA-P plus placebo<br> * To characterize the safety profile of niraparib when given with AA-P compared to AA-P with placebo<br> ;Primary end point(s): Radiographic progression-free survival (rPFS);Timepoint(s) of evaluation of this end point: While on study treatment, radiographic imaging will be performed every 8 weeks for the first 6 months and every 12 weeks thereafter;Main Objective: To evaluate the effectiveness of niraparib plus AA-P compared to AA-P plus placebo.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): * OS<br> * Time to chronic opioid use<br> * Time to pain progression<br> * Time to initiation of cytotoxic chemotherapy<br> ;Timepoint(s) of evaluation of this end point: Assessments of the secondary endpoints are variable but carried out on a regular basis from C1D1 through the follow up as described in the endpoint requirements