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Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal Cancer — CaboMAb  

Colorectal Cancer Clinical Trial

Official title:
Cabozantinib (XL184) With Panitumumab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer and Cabozantinib Monotherapy in Subjects With MET Amplified Treatment-Refractory Colorectal Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02008383
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date January 2014
Completion date August 29, 2018
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