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Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas — UTAH  

Gastrointestinal Neoplasms Clinical Trial

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

Clinical Trial Summary

Open-label dose escalation of Ulixertinib combined with fixed dose of hydroxychloroquine.

Clinical Trial Description

This is an open-label Phase I basket trial designed to determine the phase 2 recommended dose of ulixertinib in combination hydroxychloroquine. The recommended phase 2 dose (RP2D) will be determined by using a standard 3+3 dose-escalation design with a minimum of 3 evaluable subjects accrued to dose level one and two. Should dose level one be deemed intolerable, enrollment will proceed at dose level 0. The RP2D will be affirmed according to the rules of the 3+3 dose-escalation scheme ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04145297
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase Phase 1
Start date March 17, 2020
Completion date August 18, 2022
View Details
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