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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to end of study (6 years 10 months)

Awards & highlights

QUEST Trial 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.Check my eligibility

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.See study design

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.

QUEST Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

QUEST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to end of study (6 years 10 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to end of study (6 years 10 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to end of study (6 years 10 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Combination 1: Part 2 and Combination 2: Circulating Tumor Cells (CTC) Response

Combination 1: Part 2 and Combination 2: Duration of Objective Response

Combination 1: Part 2 and Combination 2: Overall Survival

+13 more

QUEST 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

Prednisone 5 mg

2012

Completed Phase 3

~570

Cetrelimab 480 mg

2018

Completed Phase 1

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,172 Total Patients Enrolled

8 Trials studying Prostate Cancer

2,178 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,769 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03431350 — Phase 1 & 2

Prostate Cancer Clinical Trial 2023: Abiraterone acetate Highlights & Side Effects. Trial Name: NCT03431350 — Phase 1 & 2

Prostate Cancer Research Study Groups: Combination 2: Dose Expansion: Niraparib + AA-P (Part 2), Combination 1:Dose Selection: Niraparib + cetrelimab (Part 1), Combination 1:Dose Expansion: Niraparib + cetrelimab (Part 2), Combination 3: Niraparib + AA-P

Abiraterone acetate (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03431350 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are researchers hoping to discover through this clinical trial?

"The primary outcome of this trial, which will be measured over a Up to Day 28 time frame is Part 2: Combinations 1: Incidence of Adverse Events (AEs). Secondary outcomes include Part 2: Combination 1: Overall Survival (OS) which is defined as OS is defined as time from start of treatment to death from any cause., Part 2: Combination 1: Duration of Objective Response which is defined as Duration of objective response is defined as time from complete response (CR) or partial response (PR) to radiographic progression of disease (PD), unequivocal clinical progression, or death, whichever occurs first"

Answered by AI

What are the primary benefits of taking Niraparib 200 mg?

"Niraparib 200 mg is a medication that can treat thyroiditis, ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are there any unfilled appointments for this experiment?

"Presently, this study is not looking for any new participants. The trial was originally posted on March 2nd, 2018 and was last updated on October 25th, 2022. If you are exploring other studies, there are presently 1292 clinical trials actively recruiting patients with prostatic cancer, castration-resistant and 472 studies for Niraparib 200 mg actively recruiting participants."

Answered by AI

How many people are being treated as part of this experiment?

"As of now, this particular trial is not recruiting any more patients. Although, it's worth noting that the study was last updated on October 25th, 2022. If you're interested in other trials, there are 1292 castration-resistant prostatic cancer studies and 472 Niraparib 200 mg trials that are still looking for participants."

Answered by AI

Are there many research facilities testing this in Canada?

"This trial has 11 enrolment sites, which are currently recruiting patients. These locations include the Michigan Institute of Urology in Troy, Centre de Recherche du CHUM in Montreal, Chesapeake Urology Research Associates in Towson and 8 other centres."

Answered by AI

Is the Niraparib 200 mg dosage unique to this particular research?

"As of now, there are 472 Niraparib 200 mg clinical trials underway. 112 of these active studies are in their third phase. Although the majority of these studies for Niraparib 200 mg originate from Duarte, California, there are 19779 locations where research is being conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

2018. "A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03431350.

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