drugset / Trial / NCT05221320
Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 600 mg | Oral |
| Subject | Ulixertinib | Small molecule | 450 mg | Oral |