ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Janssen 64091742PCR2001 | prostate | Australia
Previous Study | Return to List | Next Study

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies (Galahad)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02854436
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Niraparib Phase 2

Detailed Description:
This is a multicenter and open-label (participants and researchers are aware of the treatment that participants are receiving) study that consists of 4 phases; a Prescreening Phase for biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will continue until the study drug is discontinued), and a Follow-up Phase (every 3 months after end of treatment visit). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Niraparib
Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.
Drug: Niraparib
Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
Other Name: JNJ-64091742



Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Screening, Cycle 1 (each cycle of 28 days) Day 1 (every 8 weeks for the first 6 months and then every 12 weeks thereafter) till Follow-up Phase ]
    ORR of soft tissue disease with no evidence of bone progression in participants with in Breast Cancer gene 1 (BRCA1) or gene 2 (BRCA2). ORR is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately up to 3 years and 2 months ]
    ORR in participants with measurable metastatic castration-resistant prostate cancer (mCRPC) and DNA-repair anomalies. ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria.

  2. Circulating Tumor Cells (CTC) Response [ Time Frame: From Screening till End of Treatment (30 {+/- 5} days of last dose - approximately up to 3 years and 2 months) ]
    CTC response defined as CTC=0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0.

  3. Overall Survival (OS) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    OS is defined as time from enrollment to death from any cause.

  4. Radiographic Progression-Free Survival (rPFS) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    rPFS is defined as time from enrollment to radiographic progression or death.

  5. Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    First PSA increase that is 25 percent (%) or greater and an absolute increase of 2 nanogram/milliliter (ng/mL) or more above the nadir.

  6. Time to Symptomatic Skeletal Event (SSE) [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
    Time to SSE: time from enrollment to first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.

  7. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From enrollment to completion of study (approximately up to 3 years and 2 months) ]
  8. Duration of Objective Response [ Time Frame: From complete response (CR) or partial response (PR) to radiographic progression of disease (approximately up to 3 years and 2 months) ]
    Duration of objective response is defined as time from complete response or partial response to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded)
  • At least 1 line of taxane-based chemotherapy for the treatment of prostate cancer with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant setting
  • At least 1 line of androgen receptor (AR)-targeted therapy (for example {e.g.}, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for prostate cancer with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant setting
  • Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
  • Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry

Exclusion Criteria:

  • Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
  • Prior platinum-based chemotherapy for the treatment of prostate cancer
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854436


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 120 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02854436     History of Changes
Other Study ID Numbers: CR108208
64091742PCR2001 ( Other Identifier: Janssen Research & Development, LLC )
2016-002057-38 ( EudraCT Number )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Prostate cancer
CRPC
Metastatic castrate-resistant prostate cancer
Prostate neoplasm
Galahad
Niraparib
DNA anomalies
DNA defect
PARP inhibitor
PARPi

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Diseases
Congenital Abnormalities
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents