Experimental Treatment for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Paul Mathew, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of combination treatment d29 until 30 days after last dose of study treatment per ctcae v4, assessed up to 52 weeks

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This is a phase I study to determine the safety and feasibility of the combination of enzalutamide and niraparib in subjects with metastatic castration-resistant prostate cancer (CRPC).

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of combination treatment d29 until 30 days after last dose of study treatment per ctcae v4, assessed up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of combination treatment d29 until 30 days after last dose of study treatment per ctcae v4, assessed up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of combination treatment d29 until 30 days after last dose of study treatment per ctcae v4, assessed up to 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) for Subjects Receiving Enzalutamide With Niraparib Without Experiencing Dose-limiting Toxicity(s) (DLT)

Secondary study objectives

Objective Response (OR) Rates for All Subjects With Confirmed Partial Response (PR) or Complete Response (CR) Outcomes, Per RECIST v1.1

Progression-free Survival (PFS) With Enzalutamide and Niraparib Combination Therapy.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental TreatmentExperimental Treatment2 Interventions

Subjects will receive enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

FDA approved

Enzalutamide

FDA approved

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