Dabrafenib and/or Trametinib Rollover Study

April 18, 2024 updated by: Novartis Pharmaceuticals

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABE
        • Completed
        • Novartis Investigative Site
  • Austria
      • Innsbruck, Austria, A-6020
        • Active, not recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100036
        • Active, not recruiting
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Active, not recruiting
        • Novartis Investigative Site
  • France
      • Lyon, France, 69373
        • Active, not recruiting
        • Novartis Investigative Site
      • Nantes Cedex 1, France, 44093
        • Active, not recruiting
        • Novartis Investigative Site
      • Paris, France, 75970
        • Completed
        • Novartis Investigative Site
      • Villejuif, France, 94800
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Completed
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Active, not recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • Novartis Investigative Site
    • Baden Wuerttemberg
      • Mannheim, Baden Wuerttemberg, Germany, 68305
        • Active, not recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H 1122
        • Recruiting
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Active, not recruiting
        • Novartis Investigative Site
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277 8577
        • Completed
        • Novartis Investigative Site
    • Tokyo
      • Chuo ku, Tokyo, Japan, 104 0045
        • Completed
        • Novartis Investigative Site
  • Netherlands
      • Rotterdam, Netherlands, 3075 EA
        • Active, not recruiting
        • Novartis Investigative Site
      • Utrecht, Netherlands, 3584CX
        • Active, not recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Completed
        • Novartis Investigative Site
      • Madrid, Spain, 28050
        • Recruiting
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Songkla, Thailand, 90110
        • Active, not recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health Research Institute
        • Principal Investigator:
          • Michael Gordon
        • Contact:
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institute Of Health
        • Principal Investigator:
          • Robert Kreitman
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Completed
        • James Cancer Hospital and Solove Research Institute Ohio State
    • Texas
      • Dallas, Texas, United States, 75251
        • Completed
        • Mary Crowley Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
  • In the opinion of the Investigator would benefit from continued treatment.

Exclusion Criteria:

  • Patient has been previously permanently discontinued from study treatment in the parent protocol.
  • Patient's indication is commercially available and reimbursed in the local country.
  • Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dabrafenib monotherapy

Patients in this study may receive:

- monotherapy of dabrafenib
Drug: dabrafenib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
Experimental: trametinib monotherapy

Patients in this study may receive:

- monotherapy of trametinib
Drug: trametinib
trametinib is available in tablets (0.5mg, 2mg dose)
Experimental: Combination therapy (dabrafenib & trametinib)

Patients in this study may receive:

- the combination of dabrafenib and trametinib
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Time Frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Assessment by investigator
Time Frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
To evaluate clinical benefit as assessed by the Investigator
Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2017

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

December 21, 2027

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDRB436X2X02B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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