NCT04145297

Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DRUG	Ulixertinib	Ulixertinib will be provided as 150 mg capsules and will be self-administered twice daily by mouth at the assigned dose level. Ulixertinib Dose Level 0 300 mg PO BID, Dose Level 1 (starting dose) 450 mg PO BID, Dose Level 2 600 mg PO BID, Medication will be administered in 28-day cycles
DRUG	Hydroxychloroquine	Hydroxychloroquine will be provided as 200 mg tablets and will be self-administered by mouth twice daily. Fixed Dose 600mg POBID. Medication will be administered in 28-day cycles

Timeline

• Start date: 2020-03-17
• Primary completion: 2022-06-10
• Completion: 2022-08-18
• First posted: 2019-10-30
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study