Dabrafenib and/or Trametinib Rollover Study

Description

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

Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma

Study Overview

Study Details

Study overview

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.

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

Dabrafenib and/or Trametinib Rollover Study

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health Research Institute, Scottsdale, Arizona, United States, 85258

Bethesda

National Institute Of Health, Bethesda, Maryland, United States, 20892

Columbus

James Cancer Hospital and Solove Research Institute Ohio State, Columbus, Ohio, United States, 43210

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75251

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2027-12-21