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

NCT04502602 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Andrew Poklepovic, MD · Massey Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2024-10-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502602 on ClinicalTrials.gov