RECRUITING

Dabrafenib and/or Trametinib Rollover Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-12-28
Study Completion:2027-12-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03340506

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * In the opinion of the Investigator would benefit from continued treatment.
  1. * Patient has been previously permanently discontinued from study treatment in the parent protocol.
  2. * Patient's indication is commercially available and reimbursed in the local country.
  3. * Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
Novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Honor Health Research Institute
Scottsdale, Arizona, 85258
United States
National Institute Of Health
Bethesda, Maryland, 20892
United States
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, 43210
United States
Mary Crowley Cancer Research
Dallas, Texas, 75251
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2017-12-28
Study Completion Date2027-12-21

Study Record Updates

Study Start Date2017-12-28
Study Completion Date2027-12-21

Terms related to this study

Keywords Provided by Researchers

  • Tafinlar
  • Mekinist
  • Dabrafenib
  • Trametinib
  • Adult
  • Melanoma
  • Melanoma Stage IV
  • Metastatic Melanoma
  • Advanced Melanoma
  • Lung Cancer
  • NSLC
  • Non Small Cell Lung Cancer
  • BRAF V600 Mutation
  • BRAF Gene Mutation
  • Solid tumor
  • Rare cancers
  • High Grade Glioma

Additional Relevant MeSH Terms

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