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Dabrafenib and/or Trametinib Rollover Study

NCT03340506 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-20

No results posted yet for this study

Summary

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Conditions

Interventions

DRUG

dabrafenib

dabrafenib is available in capsules (50mg and 75mg) taken twice a day

DRUG

trametinib

trametinib is available in tablets (0.5mg, 2mg dose)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2032-12-28
Completion
2032-12-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • Japan
  • Netherlands
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
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 NCT03340506 on ClinicalTrials.gov