Protocol Summary

Protocol No.

116898 (CTMT212A0US04T; THREAD - HCI-18-GI-04)

Principal Investigator

Kinsey, Conan

Phase

I

Age Group

Adult

ClinicalTrials.Gov

NCT03825289 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Susanna Fraser
Clinical Trials Navigator
+1 801-587-4402
susanna.fraser@hci.utah.edu

Title

Phase I Trial of Trametinib and Hydroxychloroquine in Patients with Advanced Pancreatic Cancer

Objective

Primary Objective
- To assess the safety and tolerability of escalating doses of hydroxychloroquine (HCQ) in combination with a fixed dose of trametinib in subjects with metastatic or locally advanced, unresectable pancreatic ductal adenocarcinoma and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of the combination.
Primary Endpoint(s): The incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) will be collected after the first 28 day cycle.

Exploratory Objectives
- To assess the efficacy of trametinib and hydroxychloroquine in the study population.
Exploratory Endpoint: Response rate (PR and CR), progression free survival (PFS), and Overall Survival (OS) will be described.

- To evaluate the bioactivity of trametinib and hydroxychloroquine against the MEK1/2 and autophagy pathways by immunohistochemical assessment.
Exploratory Endpoint: changes in tissue levels of p62 and phosphorylation of ERK, and serum levels of p62 between baseline, 1 months of treatment, and progression or end of treatment, whichever comes first.

Applicable Disease Sites

Experimental Therapeutics; Gastrointestinal

Participating Institutions

Status

Not Open


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