drugset / Trial / NCT04502602
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
Phase 1
Active not recruiting
18 enrolled
Virginia Commonwealth University
GlaxoSmithKline · collabPuma Biotechnology, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-08-24
- Primary completion
- 2024-10-30
- Completion
- 2027-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neratinib | Small molecule | 160 mg | Oral |
| Subject | Neratinib | Small molecule | 200 mg | Oral |
| Subject | Neratinib | Small molecule | 240 mg | Oral |
| Subject | Niraparib | Small molecule | 100 mg | Oral |
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Subject | Niraparib | Small molecule | 300 mg | Oral |