NCT04502602

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-arm, open-label, phase 1/1b trial to determine the RP2D of neratinib and niraparib when given in combination to patients with advanced solid tumors. The RP2D will be identified during the phase 1 dose escalation portion of the study using a modified 3+3 design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with platinum-resistant ovarian cancer.

Conditions

• Advanced Solid Tumor
• Ovarian Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-24
• Primary completion: 2026-08-27
• Completion: 2029-05-31
• First posted: 2020-08-06
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study