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.

N/A
Principal Investigator Affiliation N/A
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, Arizona

Status

Recruiting

Address

Honor Health Research Institute

Scottsdale, Arizona, 85258

Site Contact

Angela Neuckranz

[email protected]

480-323-3990

National Institute Of Health, Bethesda, Maryland

Status

Recruiting

Address

National Institute Of Health

Bethesda, Maryland, 20892

Site Contact

Michelle Capozzoli

[email protected]

1-888-669-6682

Columbus, Ohio

Status

Completed

Address

James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio, 43210

Mary Crowley Cancer Research, Dallas, Texas

Status

Completed

Address

Mary Crowley Cancer Research

Dallas, Texas, 75251

International Sites

Novartis Investigative Site, Buenos Aires, Argentina

Status

Completed

Address

Novartis Investigative Site

Buenos Aires, , C1125ABE

Novartis Investigative Site, Innsbruck, Austria

Status

Active, not recruiting

Address

Novartis Investigative Site

Innsbruck, , A-6020

Novartis Investigative Site, Beijing, China

Status

Active, not recruiting

Address

Novartis Investigative Site

Beijing, , 100036

Novartis Investigative Site, Copenhagen, Denmark

Status

Active, not recruiting

Address

Novartis Investigative Site

Copenhagen, , DK-2100

Novartis Investigative Site, Lyon, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Lyon, , 69373

Novartis Investigative Site, Nantes Cedex 1, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Nantes Cedex 1, , 44093

Novartis Investigative Site, Paris, France

Status

Completed

Address

Novartis Investigative Site

Paris, , 75970

Novartis Investigative Site, Villejuif, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Villejuif, , 94800

Novartis Investigative Site, Mannheim, Baden Wuerttemberg, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Mannheim, Baden Wuerttemberg, 68305

Novartis Investigative Site, Berlin, Germany

Status

Completed

Address

Novartis Investigative Site

Berlin, , 13353

Novartis Investigative Site, Hamburg, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Hamburg, , 20246

Novartis Investigative Site, Heidelberg, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Heidelberg, , 69120

Novartis Investigative Site, Budapest, Hungary

Status

Recruiting

Address

Novartis Investigative Site

Budapest, , H 1122

Novartis Investigative Site, Debrecen, Hungary

Status

Active, not recruiting

Address

Novartis Investigative Site

Debrecen, , 4032

Novartis Investigative Site, Kashiwa, Chiba, Japan

Status

Completed

Address

Novartis Investigative Site

Kashiwa, Chiba, 277 8577

Novartis Investigative Site, Chuo ku, Tokyo, Japan

Status

Completed

Address

Novartis Investigative Site

Chuo ku, Tokyo, 104 0045

Novartis Investigative Site, Rotterdam, Netherlands

Status

Active, not recruiting

Address

Novartis Investigative Site

Rotterdam, , 3075 EA

Novartis Investigative Site, Utrecht, Netherlands

Status

Active, not recruiting

Address

Novartis Investigative Site

Utrecht, , 3584CX

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, Catalunya, 08035

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28040

Novartis Investigative Site, Madrid, Spain

Status

Completed

Address

Novartis Investigative Site

Madrid, , 28041

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28050

Novartis Investigative Site, Songkla, Thailand

Status

Active, not recruiting

Address

Novartis Investigative Site

Songkla, , 90110

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