Dabrafenib and/or Trametinib Rollover Study

NCT03340506 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: CDRB436X2X02B2023-509318-13-00
• Study Type: interventional
• Target: 100
• Locations: 12 countries
• Sites: 28

Brief 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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination

  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 Outcomes (1)

• Clinical Benefit Assessment by 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.

Study Arms (3)

dabrafenib monotherapy

EXPERIMENTAL

Patients in this study may receive: \- monotherapy of dabrafenib

Drug: dabrafenib

trametinib monotherapy

EXPERIMENTAL

Patients in this study may receive: \- monotherapy of trametinib

Drug: trametinib

Combination therapy (dabrafenib & trametinib)

EXPERIMENTAL

Patients in this study may receive: \- the combination of dabrafenib and trametinib

Drug: dabrafenib; Drug: trametinib

Interventions

dabrafenib DRUG

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

Combination therapy (dabrafenib & trametinib); dabrafenib monotherapy

trametinib DRUG

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

Combination therapy (dabrafenib & trametinib); trametinib monotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

ACTIVE NOT RECRUITING

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

National Institute Of Health

Bethesda, Maryland, 20892, United States

ACTIVE NOT RECRUITING

James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio, 43210, United States

COMPLETED

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

COMPLETED

Novartis Investigative Site

Caba, Buenos Aires, C1121ABE, Argentina

COMPLETED

Novartis Investigative Site

Innsbruck, Tyrol, 6020, Austria

ACTIVE NOT RECRUITING

Novartis Investigative Site

Beijing, 100036, China

COMPLETED

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

ACTIVE NOT RECRUITING

Novartis Investigative Site

Lyon, 69373, France

ACTIVE NOT RECRUITING

Novartis Investigative Site

Nantes, 44093, France

ACTIVE NOT RECRUITING

Novartis Investigative Site

Paris, 75970, France

COMPLETED

Novartis Investigative Site

Villejuif, 94800, France

COMPLETED

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany

COMPLETED

Novartis Investigative Site

Berlin, 13353, Germany

COMPLETED

Novartis Investigative Site

Hamburg, 20246, Germany

COMPLETED

Novartis Investigative Site

Heidelberg, 69120, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

COMPLETED

Novartis Investigative Site

Budapest, H 1122, Hungary

COMPLETED

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

COMPLETED

Novartis Investigative Site

Chuo Ku, Tokyo, 1040045, Japan

COMPLETED

Novartis Investigative Site

Rotterdam, South Holland, 3015 GD, Netherlands

COMPLETED

Novartis Investigative Site

Utrecht, 3584 CX, Netherlands

ACTIVE NOT RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28040, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28041, Spain

COMPLETED

Novartis Investigative Site

Madrid, 28050, Spain

RECRUITING

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Glioma; Lung Neoplasms

Interventions

dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: December 28, 2017
• Primary Completion (Estimated): December 28, 2032
• Study Completion (Estimated): December 28, 2032
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); DK (1); FR (4); HU (2); JP (2); DE (4); NL (2); ES (4); TH (1); CN (1); AR (1); US (5)