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A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma

NCT03391050 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-07-31

No results posted yet for this study

Summary

The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and dabrafenib therapy regimen in patients with BRAFV600 mutant unresectable and/or metastatic cutaneous melanoma resistant to the dabrafenib/trametinib combination. In addition, the study aims to assess the safety profile of the combined APR-246 and dabrafenib therapy regimen, to explore potential biomarkers, and to further describe the anti-tumour activity of the combination of APR-246 and dabrafenib. The trial will enroll up to 31 evaluable patients.

Conditions

Interventions

DRUG

APR-246

Intravenous infusion

DRUG

Dabrafenib

Oral administration

Sponsors & Collaborators

  • Jules Bordet Institute

    collaborator OTHER

  • Aprea Therapeutics

    lead INDUSTRY

Principal Investigators

  • Ahmad Awada, PhD · Jules Bordet Institute, Brussels, Belgium

  • Joseph Kerger, MD · Jules Bordet Institute, Brussels, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2018-08-08
Completion
2018-08-08

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT03391050 on ClinicalTrials.gov