Solid Tumor Clinical Trial
Official title:
Phase I Study to Evaluate the Safety of Neratinib in Combination With Paclitaxel, Trastuzumab and Pertuzumab in Women and Men With Advanced or Metastatic HER2+ Solid Tumors
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.
Neratinib is a potent, irreversible, small molecule panErbB inhibitor of EGFR, HER2 and HER4
tyrosine kinases. Its activity prevents the autophosphorylation of HER2 and thus halts the
downstream activation of this key proliferative pathway in tumors dependent on HER2
overexpression or EGFR activation. It has shown promising clinical activity in women with
HER2+ stage 2 and 3 breast cancer in the neoadjuvant setting (I-SPY 2 TRIAL) and in women
with stage 4 metastatic breast cancer, although evaluation in larger phase 3 trials is
required to confirm these results.
The rationale for this study is to determine the feasibility of adding neratinib to a taxane
based chemotherapy and the approved HER2 antagonists, trastuzumab and pertuzumab.
The study will evaluate the safety and tolerability and recommended dose of daily neratinib
in combination with weekly paclitaxel, trastuzumab and tri-weekly pertuzumab in patients with
HER2+ advanced or metastatic disease and, if successful, determine an optimal dose to move
into phase II/III testing of this combination in the neoadjuvant setting.
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