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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04502602
Study type Interventional
Source Virginia Commonwealth University
Contact Massey SIIT Team
Phone 804-628-9238
Email masseysiit@vcu.edu
Status Recruiting
Phase Phase 1
Start date August 24, 2020
Completion date May 31, 2029

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