drugset
drugset / Trial / NCT02593708

Phase1 of Neratinib+Trastuzumab, Pertuzumab, Paclitaxel in Patients With Advanced Solid Tumors/HER2+

NCT02593708 ↗

Phase 1 Terminated 6 enrolled Michelle Melisko
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the safety and tolerability of the combination of neratinib plus paclitaxel, trastuzumab and pertuzumab to determine the recommended Phase II/III dose of this combination. Neratinib will be given once daily days 1-21 and should be taken orally with food. Paclitaxel and trastuzumab will be given IV on days 1, 8, and 15 out of 21 day cycles. Pertuzumab will be given IV every 3 weeks on day 1 out of 21-day cycles. Each cycle will be 21 days in duration. Patients will continue on treatment until disease progression or intolerable toxicity.

Timeline

Start
2015-11-03
Primary completion
2017-01-05
Completion
2017-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Neratinib Small molecule 80 mg Oral
Subject Neratinib Small molecule 120 mg Oral
Subject Neratinib Small molecule 160 mg Oral
Subject Neratinib Small molecule 200 mg Oral
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Pertuzumab Monoclonal antibody 420 mg Intravenous
Background Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications

cancer