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

NCT04145297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-18

No results posted yet for this study

Summary

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

Conditions

  • Gastrointestinal Neoplasms

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-17
Primary Completion
2022-06-10
Completion
2022-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145297 on ClinicalTrials.gov