Protocol Summary

Protocol No.

127114 (UTAH)

Principal Investigator

Kinsey, Conan

Phase

I

Age Group

Adult

ClinicalTrials.Gov

NCT04145297 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Mary Wang
+1 801-213-4266
mary.wang@hci.utah.edu

Title

UTAH: A Phase I Trial of Ulixertinib (BVD-523) and Hydroxychloroquine in Patients with Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

Objective

Primary Objective
* To assess the recommended phase 2 dose of ulixertinib in combination with a fixed dose of hydroxychloroquine in subjects with advanced, RAS, non-V600 BRAF, ERK or MEK mutated gastrointestinal malignancies.
Secondary Objectives
* To assess the safety and tolerability of ulixertinib and hydroxychloroquine in the study population. * To assess the efficacy of ulixertinib and hydroxychloroquine in the study population.
Exploratory Objectives
* To evaluate the bioactivity of ulixertinib and hydroxychloroquine against ERK1/2 and autophagy pathways. * To explore mechanisms of primary refractory, secondary resistance, and biomarkers of response to ulixertinib and hydroxychloroquine.

Applicable Disease Sites

Experimental Therapeutics; Gastrointestinal

Participating Institutions

Huntsman Cancer Institute

Status

Open


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