Protocol Summary

Protocol No.

87144 (CMEK162AUS12T; MEK-FOLFIRI)

Principal Investigator

Garrido-Laguna, Ignacio

Phase

I

Age Group

Adult

ClinicalTrials.Gov

NCT02613650 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Arun Athithan
Clinical Research Coord
+1 801-587-4624
arun.athithan@hci.utah.edu

Title

Phase IB Trial of a Combination of mFOLFIRI with MEK162 in Patients with Advanced KRAS Positive Metastatic Colorectal Cancers

Objective

Primary Objectives:
* To determine the MTD of the combination of FOLFIRI and MEK162.

Secondary Objectives:
* To evaluate response rate
* To evaluate clinical benefit rate (PR/CR/SD at 4 months)
* Additional safety

Exploratory Objectives:
* To evaluate the pharmacokinetic profile of MEK162 in combination with FOLFIRI.
* To evaluate preliminary anti-tumor activity
* To evaluate tumor dynamics using plasma samples as surrogate tissue
* To assess the sensitivity and specificity of the growth factor receptor network genomic profiles, including MEK, to predict response to FOLFIRI plus MEK162 in mCRC

Applicable Disease Sites

Experimental Therapeutics; Gastrointestinal

Participating Institutions

Huntsman Cancer Institute

Status

Open


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