A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

August 19, 2016

Primary Completion Date

November 23, 2022

Study Completion Date

December 21, 2022

Conditions
Advanced KRAS Positive Metastatic Colorectal Cancer
Interventions
DRUG

MEK162 and mFOLFIRI

"MEK162 in combination with mFOLFIRI in a 14 day cycle~MEK162 will be given single agent 6 day lead in and then will be given in combination with mFOLFIRI~mFOLFIRI Administered Day 1 of each cycle Irinotecan 180mg/m2 iv over 90 minutes on day 1 5-fluoruracil 1200mg/m2 continuous infusion for 48 hours (2400mg/m2 in 48 hours)~Followed by MEK162 - Taken twice daily orally on Days 1-12 of each cycle~Level -1: mFOLFIRI at 80% + MEK162 30 mg twice daily 1 week on and 1 week off Level 1: mFOLFIRI + MEK162 30 mg twice daily Level 2: mFOLFIRI + MEK162 45 mg twice daily"

Trial Locations (1)

84112

Huntsman Cancer Institute, Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

University of Utah

OTHER