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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03592641
Phase
PHASE2
Status
Terminated

Conditions

  • Colorectal Carcinoma
  • Metastatic Colon Adenocarcinoma
  • Metastatic Rectal Adenocarcinoma
  • Stage III Colon Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Colon Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Colon Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Colon Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Rectal Cancer AJCC v8
  • Stage IVA Colon Cancer AJCC v8
  • Stage IVA Rectal Cancer AJCC v8
  • Stage IVB Colon Cancer AJCC v8
  • Stage IVB Rectal Cancer AJCC v8
  • Stage IVC Colon Cancer AJCC v8
  • Stage IVC Rectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Unresectable Rectal Adenocarcinoma

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Jul 25, 2019
Status verified
Sep 2023
Primary completion
Jul 31, 2021
Completion
Dec 30, 2021

Study Design

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

Arms

  • Experimental: Treatment (savolitinib)
    Patients receive savolitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From start of treatment until documented progression of disease (up to 4 months) ]

Locations (33)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Smilow Cancer Hospital-Derby Care CenterDerbyConnecticut06418-
Smilow Cancer Hospital Care Center-FairfieldFairfieldConnecticut06824-
Smilow Cancer Hospital Care Center - GuilfordGuilfordConnecticut06437-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Yale-New Haven Hospital North Haven Medical CenterNorth HavenConnecticut06473-
Smilow Cancer Hospital-Orange Care CenterOrangeConnecticut06477-
Smilow Cancer Hospital-Torrington Care CenterTorringtonConnecticut06790-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
Smilow Cancer Hospital-Waterbury Care CenterWaterburyConnecticut06708-
Smilow Cancer Hospital Care Center - WaterfordWaterfordConnecticut06385-
University of Florida Health Science Center - GainesvilleGainesvilleFlorida32610-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Kansas Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
NYU Winthrop HospitalMineolaNew York11501-
Bellevue Hospital CenterNew YorkNew York10016-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Duke University Medical CenterDurhamNorth Carolina27710-
Parkland Memorial HospitalDallasTexas75235-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CASmilow Cancer Hospital-Derby Care Center· Derby, CTSmilow Cancer Hospital Care Center-Fairfield· Fairfield, CTSmilow Cancer Hospital Care Center - Guilford· Guilford, CT

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