GALAHAD PCR2001

Study StatusEnrolling
ProtocolPCR2001
SponsorJanssen
Study Description

A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Primary Endpoint

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies

Inclusion Criteria

-Subject must be a man age ≥ 18 years of age

  • Histologically confirmed prostate cancer
  • At least 1 line of taxane-based chemotherapy
  • At least 1 line of Androgen Receptor (AR) targeted therapy
  • Biomarker positive sample for deoxyribonucleic acid (DNA) repair anomalies
  • Progression of metastatic prostate cancer in the setting of castrate levels of testosterone ≤ 50 ng/dL)on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry defined as having one or more of the following: (a) Prostate Specific Antigen (PSA) progression defined by a minimum of 2 rising PSA levels with an interval of >=1 week between each determination. The PSA level at the screening visit should be >=2 mcg/L [2 ng/mL], (b) Radiographic progression of soft tissue or bone disease by Prostate Cancer Working Group 3 (PCWG3) criteria

-ECOG PS grade of 0 or ≤ 2

-Adequate hematologic function defined as:

  • ANC ≥1.50 x 109/L
  • Platelets ≥150 x 109/L
  • Hgb ≥9g/dL

-Adequate liver function defined as:

  • ALT and AST ≤ 3.0 times the upper limit of normal (ULN). If the liver has tumor involvement AST and ALT equaling ≤5 times ULN is acceptable.
  • Total bilirubin ≤1.5 times ULN or direct bilirubin ≤1 times ULN

-Adequate renal function defined as: Creatinine ≤1.5 times ULN or Creatinine Clearance >60 mL/min Cockcroft-Gault formula.
-Serum Potassium ≥3.5 mmol/L

-Agrees to use a condom if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant during an 3 months after the last study drug administration. Must also agree not to donate sperm during the study.

Exclusion Criteria

- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
- Prior platinum-based chemotherapy
- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- Known symptomatic or impending cord compression
- Known symptomatic uncontrolled brain or leptomeningeal metastases (Day 1)
- Known allergies to, hypersensitivity or intolerance to niraparib or its excipients
- Know disorder affecting GI absorption.
- Active cancer (other than prostate cancer; or basal cell cancer or squamous cell skin cancer, non-muscle invasive bladder cancer, or other cancer in-situ currently in complete remission) within 2 years prior to cycle 1/day 1
- Prior radiotherapy ≤15 days prior to Cycle1 Day1, except single fraction of radiotherapy for the purposes of palliation.
- Prolonged corrected QT interval by the Fridericia correction formula (QtcF) on screening ECG >470 msec.
- Receiving concomitant medications that prolong Qtc and are unable to be discontinued while receiving study drug.
- History of clinically significant ventricular arrhythmia
- ≤30 days prior to Cycle1 Day1 received or had: a transfusion, chemotherapy, hematopoietic growth factors, investigational agent for prostate cancer, major surgery, new or adjusted dose of zoledronic acid or deosumab.
- Refer to protocol for HIV positive patients.

Side Effects

Fatigue, nausea, anemia , constipation, thrombocytopenia, vomiting, decreased appetite, neutropenia, headache, diarrhea, dyspnea, cough, leukopenia

Interested in enrolling in this trial? Please call 717-431-2285.


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