Cetuximab and Savolitinib Treatment of Ras Wild-Type Colorectal Cancer

Sponsor
Yale University
Study ID
NCT02630420
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cetuximab and savolitinib — DRUG
    Dosage of combined cetuximab and savolitinib will be determine in Part 1 of the study, Part 2 will use the findings of Part 1 to further assess safety and to assess efficacy of this drug combination.

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Oct 2017
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

Safety and tolerability based on regular clinical assessment and NCI Common Terminology Criteria for Adverse Events [ Time Frame: start of treatment to 3 years from treatment initiation ]

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