NCT04502602View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 24, 2020

Primary Completion Date

August 27, 2026

Study Completion Date

May 31, 2029

Conditions
Advanced Solid TumorOvarian Cancer
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

Trial Locations (1)

23298

Virginia Commonwealth University, Richmond

Sponsors

Collaborators (1)

GlaxoSmithKline
All Listed Sponsors
collaborator

Puma Biotechnology, Inc.

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

Virginia Commonwealth University

OTHER

NCT04502602 - Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer | Biotech Hunter | Biotech Hunter