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ACTIVE NOT RECRUITING
NCT04502602
PHASE1

Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month progression-free survival \[PFS\]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer in Phase 1b.

Official title: A Phase 1/1b Clinical Trial of Niraparib and Neratinib in Advanced Solid Tumors With an Expansion Cohort in Platinum-resistant Ovarian Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2020-08-24

Completion Date

2029-05-31

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

DRUG

Neratinib 160 mg

Escalating doses to determine recommended phase 2 dose (RP2D)

DRUG

Neratinib 200 mg

Determined RP2D dose

DRUG

Neratinib 240 mg

Escalating doses to determine recommended phase 2 dose (RP2D)

DRUG

Niraparib 100 mg

Escalating doses to determine recommended phase 2 dose (RP2D)

DRUG

Niraparib 200 mg

Escalating doses to determine recommended phase 2 dose (RP2D)

DRUG

Niraparib 300 mg

Phase 1: Escalating doses to determine recommended phase 2 dose (RP2D)

DRUG

Niraparib at RP2D

Phase 1b: Determined dose

DRUG

Neratinib at RP2D

Phase 1b: Determined dose

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States