Phase1 of Neratinib+Trastuzumab, Pertuzumab, Paclitaxel in Patients With Advanced Solid Tumors/HER2+
Status:
Terminated
Trial end date:
2017-07-31
Target enrollment:
Participant gender:
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.