Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen by John H Strickler

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well savolitinib works in treating patients with MET amplified colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Savolitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1,500/mcL

Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 80%)

Total bilirubin (TBL) > ULN =<1.5 × ULN with ALT and AST =< 1x ULN

Exclusion Criteria

Cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g. cytokines or antibodies) within 3 weeks of first dose of study treatment

Not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from adverse events due to all prior anti-cancer therapies except alopecia, oxaliplatin-related neuropathy, and other non-clinically significant adverse events

You cannot have received any experimental drugs 21 days before starting the study treatment.

Participant Groups

Group I: Treatment (savolitinib) Experimental Treatment 1 Intervention

Patients receive savolitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Savolitinib is already approved in China for the following indications:

🇨🇳 Approved in China as Orpathys for:

• Non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Smilow Cancer Hospital Care Center - Guiford Guilford, CT

Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, NY

University of Florida Health Science Center - Gainesville Gainesville, FL

Yale-New Haven Hospital North Haven Medical Center North Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References