Dabrafenib and/or Trametinib Rollover Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03340506
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Austria, China, Denmark, France, Germany, Hungary, Japan, Netherlands, Spain, Thailand, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Arms

Experimental: dabrafenib monotherapy

Patients in this study may receive: - monotherapy of dabrafenib

Experimental: trametinib monotherapy

Patients in this study may receive: - monotherapy of trametinib

Experimental: Combination therapy (dabrafenib & trametinib)

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

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Honor Health Research Institute, Scottsdale 5313457, Arizona 5551752

Status

Recruiting

Address

Honor Health Research Institute

Scottsdale 5313457, Arizona 5551752, 85258

Site Contact

Lee Davis

[email protected]

480-323-3990

National Institute Of Health, Bethesda 4348599, Maryland 4361885

Status

Recruiting

Address

National Institute Of Health

Bethesda 4348599, Maryland 4361885, 20892

Site Contact

Paul Hoffmeister

[email protected]

1-888-669-6682

Columbus 4509177, Ohio 5165418

Status

Completed

Address

James Cancer Hospital and Solove Research Institute Ohio State

Columbus 4509177, Ohio 5165418, 43210

Mary Crowley Cancer Research, Dallas 4684888, Texas 4736286

Status

Completed

Address

Mary Crowley Cancer Research

Dallas 4684888, Texas 4736286, 75251

International Sites

Novartis Investigative Site, Buenos Aires 3435910, Argentina

Status

Completed

Address

Novartis Investigative Site

Buenos Aires 3435910, , C1125ABE

Novartis Investigative Site, Innsbruck 2775220, Tyrol 2763586, Austria

Status

Active, not recruiting

Address

Novartis Investigative Site

Innsbruck 2775220, Tyrol 2763586, 6020

Novartis Investigative Site, Beijing 1816670, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Beijing 1816670, , 100036

Novartis Investigative Site, Copenhagen 2618425, Denmark

Status

Active, not recruiting

Address

Novartis Investigative Site

Copenhagen 2618425, , DK-2100

Novartis Investigative Site, Lyon 2996944, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Lyon 2996944, , 69373

Novartis Investigative Site, Nantes 2990969, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Nantes 2990969, , 44093

Novartis Investigative Site, Paris 2988507, France

Status

Completed

Address

Novartis Investigative Site

Paris 2988507, , 75970

Novartis Investigative Site, Villejuif 2968705, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Villejuif 2968705, , 94800

Novartis Investigative Site, Mannheim 2873891, Baden-Wurttemberg 2953481, Germany

Status

Completed

Address

Novartis Investigative Site

Mannheim 2873891, Baden-Wurttemberg 2953481, 68305

Novartis Investigative Site, Berlin 2950159, Germany

Status

Completed

Address

Novartis Investigative Site

Berlin 2950159, , 13353

Novartis Investigative Site, Hamburg 2911298, Germany

Status

Completed

Address

Novartis Investigative Site

Hamburg 2911298, , 20246

Novartis Investigative Site, Heidelberg 2907911, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Heidelberg 2907911, , 69120

Novartis Investigative Site, Budapest 3054643, Hungary

Status

Completed

Address

Novartis Investigative Site

Budapest 3054643, , H 1122

Novartis Investigative Site, Debrecen 721472, Hungary

Status

Completed

Address

Novartis Investigative Site

Debrecen 721472, , 4032

Novartis Investigative Site, Kashiwa 1859924, Chiba 2113014, Japan

Status

Completed

Address

Novartis Investigative Site

Kashiwa 1859924, Chiba 2113014, 277 8577

Novartis Investigative Site, Chuo Ku, Tokyo 1850144, Japan

Status

Completed

Address

Novartis Investigative Site

Chuo Ku, Tokyo 1850144, 104 0045

Novartis Investigative Site, Rotterdam 2747891, South Holland 2743698, Netherlands

Status

Completed

Address

Novartis Investigative Site

Rotterdam 2747891, South Holland 2743698, 3015 GD

Novartis Investigative Site, Utrecht 2745912, Netherlands

Status

Active, not recruiting

Address

Novartis Investigative Site

Utrecht 2745912, , 3584

Novartis Investigative Site, Barcelona 3128760, Catalonia 3336901, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona 3128760, Catalonia 3336901, 08035

Novartis Investigative Site, Madrid 3117735, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid 3117735, , 28040

Novartis Investigative Site, Madrid 3117735, Spain

Status

Completed

Address

Novartis Investigative Site

Madrid 3117735, , 28041

Novartis Investigative Site, Madrid 3117735, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid 3117735, , 28050

Novartis Investigative Site, Songkhla 1606147, Hat Yai, Thailand

Status

Active, not recruiting

Address

Novartis Investigative Site

Songkhla 1606147, Hat Yai, 90110

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