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Androgen Receptor Inhibitor

Niraparib Combinations for Prostate Cancer (QUEST Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1 (except alopecia or Grade <= 2 neuropathy) at screening

Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1

Must not have

Active infection requiring systemic therapy

Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 37 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different doses of a new cancer drug, and how well it works with other drugs, in men with prostate cancer that has spread and is resistant to treatment.

Who is the study for?

Men with metastatic castration-resistant prostate cancer who've had disease progression during treatment with abiraterone acetate and PARPi, or stopped these treatments due to side effects. They must have a good performance status (able to carry out daily activities) and resolved any previous treatment toxicities to an acceptable level. Participants should not donate sperm during the trial.

What is being tested?

The study is testing combinations of Niraparib with other drugs like Prednisone, Cetrelimab, and Abiraterone acetate in different doses for treating advanced prostate cancer. It aims to find the best dose for phase 2 trials, assess how well tumors respond, check safety, and understand how Niraparib and Abiraterone are absorbed together.

What are the potential side effects?

Possible side effects include fatigue, nausea, vomiting, low blood counts that can increase infection risk or cause bleeding problems; heart issues; liver function changes; shortness of breath; rash; muscle pain; insomnia; headache; coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Side effects from my previous cancer treatments are mild or gone, except for hair loss or some nerve issues.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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My condition worsened on AA and PARPi treatment, or I stopped due to side effects.

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I have brain metastases that are causing symptoms.

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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I am not allergic to niraparib or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 37 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 37 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 37 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Combination 1: Part 1: Number of Participants With Specified Toxicity

Combination 1: Part 2: Number of Participants With Adverse Events (AEs)

Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Combination 3: Niraparib + AA-PExperimental Treatment3 Interventions

Participants will be assigned to one of three cohorts to receive AA-P with or without niraparib. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Group II: Combination 2: Dose Expansion: Niraparib + AA-P (Part 2)Experimental Treatment3 Interventions

Participants will be assigned to one of 4 cohorts based on biomarker status - Cohort 2A (BRCA biallelic loss), 2B (other DRD biallelic loss), 2C (BRCA monoallelic loss), or 2D (other DRD monoallelic loss), and will receive niraparib 200 mg once daily in combination with abiraterone acetate 1000 mg (4\*250 mg) plus 10 mg prednisone (5 mg twice daily) throughout treatment phase. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Group III: Combination 1:Dose Selection: Niraparib + cetrelimab (Part 1)Experimental Treatment3 Interventions

Dose regimen 1: The participants will receive niraparib 200 milligram (mg) orally once daily in combination with cetrelimab 240 mg intravenously (IV) once every 2 weeks. Dose regimen 2: The participants will receive niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV once every 4 weeks in 28-day treatment cycles until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. The safety evaluation team (SET) will determine if an additional cohort is necessary, based on the data from dose regimens 1 and 2. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Group IV: Combination 1:Dose Expansion: Niraparib + cetrelimab (Part 2)Experimental Treatment2 Interventions

Participants will be assigned to either Cohort 1A (Biomarker \[BM\] positive \[+\]) or Cohort 1B (BM negative \[-\]) and will receive established RP2D of cetrelimab and niraparib, in Part 2 until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. A futility analysis will be performed for the Cohort 1B after 10 BM- participants are enrolled in Part 2. This cohort will be closed if the response is less than predetermined response rate as outlined in the protocol. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetrelimab 480 mg

2018

Completed Phase 1

~40

Prednisone 5 mg

2012

Completed Phase 3

~570