Spots Global Cancer Trial Database for Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas
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Trial Identification
Brief Title: Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas
Official Title: A Phase I Trial of Ulixertinib (BVD-523) and Hydroxychloroquine in Patients With Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas
Study ID: NCT04145297
Conditions
Study Description
Brief Summary: Open-label dose escalation of Ulixertinib combined with fixed dose of hydroxychloroquine.
Detailed 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
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