Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2018-08-29
Target enrollment:
Participant gender:
Summary
There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2)
the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the
Combination Dose Finding cohort and the Combination Expansion cohort, we will combine
cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer
(CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET
gene amplification ("MET amplification"). Patients with MET amplification will receive
cabozantinib only (monotherapy).
The primary objective of this open-label phase Ib trial are:
1. To determine the maximum tolerated dose and the recommended phase II dose for the
combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic
colorectal cancer and
2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients
with prospectively identified MET amplified metastatic colorectal cancer.
The secondary objectives are:
1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab.
2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab.
3. To describe the safety and tolerability of cabozantinib monotherapy in patients with MET
amplified colorectal cancer.
4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients with
MET amplified colorectal cancer.