Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT04515394
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tepotinib — DRUG
    Participants received Tepotinib film-coated tablets at a dose of 500 milligrams (mg) orally, once daily (QD) until disease progression (according to Response Evaluation Criteria in Solid Tumors Version 1.1 \[RECIST v1.1\]), death, Adverse event (AE) leading to discontinuation, study withdrawal, or withdrawal of consent, whichever occurs first.
  • Cetuximab — BIOLOGICAL
    Participants received weekly intravenous infusions of Cetuximab at a dose of 250 milligrams per square meter (mg/m\^2) until disease progression (according to Response Evaluation Criteria in Solid Tumors Version 1.1 \[RECIST v1.1\]), death, Adverse event (AE) leading to discontinuation, study withdrawal, or withdrawal of consent, whichever occurs first.

Study Details

The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.

Key Dates

Start date
Jan 28, 2021
Status verified
Nov 2022
Primary completion
Mar 14, 2022
Completion
Mar 31, 2022

Study Design

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

Arms

  • Experimental: Tepotinib + Cetuximab

Primary Outcome Measure

Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0 [ Time Frame: Day 1 to Day 21 of Cycle 1 (each cycle is of 21 days) ]

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
Moores Cancer CenterLa JollaCalifornia92093-
University of California, Los Angeles (UCLA)Santa MonicaCalifornia90404-
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Mayo Clinic HospitalJacksonvilleFlorida322224-1865-
Cancer Center of KansasWichitaKansas67214-3728-
Mayo ClinicRochesterMinnesota55905-
North Shore-LIJ Monter Cancer CenterLake SuccessNew York11042-
Allegheny-Singer Research InstitutePittsburghPennsylvania15212-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Scott & White Vasicek Cancer Treatment CenterTempleTexas76508-0001-
Seattle Cancer Care AllianceSeattleWashington98109-1023-
Aurora Cancer Care - Milwaukee WestWauwatosaWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Mayo Clinic· Phoenix, AZMoores Cancer Center· La Jolla, CAUniversity of California, Los Angeles (UCLA)· Santa Monica, CAGeorgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCMayo Clinic Hospital· Jacksonville, FLCancer Center of Kansas· Wichita, KS

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