Niraparib for Penile Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Moffitt Cancer Center, Tampa, FL
Penile Carcinoma+2 More
Niraparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.

Eligible Conditions

  • Penile Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Penile Carcinoma

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: Up to 24 months

Up to 24 months
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Penile Carcinoma

Trial Design

1 Treatment Group

Dostarlimab and Niraparib treatment
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Dostarlimab and Niraparib treatmentExperimental Group · 2 Interventions: Dostarlimab, Niraparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2017
Completed Phase 2
~790

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: Moffitt Cancer Center · Tampa, FL
Photo of moffitt cancer center 1Photo of moffitt cancer center 2Photo of moffitt cancer center 3
2009First Recorded Clinical Trial
1 TrialsResearching Penile Carcinoma
222 CompletedClinical Trials

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
486 Previous Clinical Trials
123,377 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,621 Previous Clinical Trials
7,937,058 Total Patients Enrolled
Jad Chahoud, MD, MPHPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a life expectancy of at least 12 weeks.
Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting or post platinum-based chemotherapy, including in a neoadjuvant or adjuvant setting or in combination with radiation therapy.
You must give written, informed consent to participate in the study and follow the study procedures.
You have stage III or stage IV penile cancer.
You have a measurable disease per iRECIST.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.