drugset / Trial / NCT05221320

Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

NCT05221320

Phase 2 Terminated 47 enrolled BioMed Valley Discoveries, Inc
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages. The opening of stage two will be dependent on the observed responses in the patients enrolled in the first stage.

Timeline

Start
2022-05-26
Primary completion
2024-05-08
Completion
2024-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 600 mg Oral
Subject Ulixertinib Small molecule 450 mg Oral