Cetuximab and Savolitinib Treatment of Ras Wild-Type Colorectal Cancer
- Registration Number
- NCT02630420
- Lead Sponsor
- Yale University
- Brief Summary
Two-part phase 1B clinical trial combining cextuximab and savolitinib for treating Ras wild-type colorectal cancer (CRC). Part 1 will assess the safety and tolerability of this drug combination and will include patients with squamous cell carcinoma of the head and neck cancer, as well as patients with CRC. Part 2 of the study, the focus of this registration, will obtain further safety data for the combination of cextuximab and savolitinib and will look at the efficacy of cextuximab and savolitinib in Ras wild-type mCRC that was previously treated and relapsed on cetuximab or panitumumab.Correlative studies will examine tumor and blood specimens for mechanisms of anti-EGFR resistance and response to MET inhibition.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cetuximab and savolitinib cetuximab and savolitinib Following assessment in Part 1 of dose-limiting toxicity and maximum tolerated dose, this drug combination will be administered in Part 2 of the study to assess safety, tolerability, response rate, and progression-free survival.
- Primary Outcome Measures
Name Time Method Safety and tolerability based on regular clinical assessment and NCI Common Terminology Criteria for Adverse Events start of treatment to 3 years from treatment initiation
- Secondary Outcome Measures
Name Time Method Response to treatment measured by RECIST (Response Evaluation Criteria in Solid tumors) criteria start of treatment to disease progression/recurrence, up to 3 years Progression free survival start of treatment to disease progression, up to 3 years