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Dabrafenib and/or Trametinib Rollover Study

NCT ID: NCT03340506

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-28

Study Completion Date

2030-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dabrafenib monotherapy

Patients in this study may receive:

\- monotherapy of dabrafenib

Group Type EXPERIMENTAL

dabrafenib

Intervention Type DRUG

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

trametinib monotherapy

Patients in this study may receive:

\- monotherapy of trametinib

Group Type EXPERIMENTAL

trametinib

Intervention Type DRUG

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

Combination therapy (dabrafenib & trametinib)

Patients in this study may receive:

\- the combination of dabrafenib and trametinib

Group Type EXPERIMENTAL

dabrafenib

Intervention Type DRUG

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

trametinib

Intervention Type DRUG

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

Interventions

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dabrafenib

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

Intervention Type DRUG

trametinib

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Honor Health Research Institute

Scottsdale, Arizona, United States

Site Status RECRUITING

National Institute Of Health

Bethesda, Maryland, United States

Site Status RECRUITING

James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio, United States

Site Status COMPLETED

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status COMPLETED

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Site Status COMPLETED

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status COMPLETED

Novartis Investigative Site

Copenhagen, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Lyon, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Nantes, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Paris, , France

Site Status COMPLETED

Novartis Investigative Site

Villejuif, , France

Site Status COMPLETED

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Site Status COMPLETED

Novartis Investigative Site

Berlin, , Germany

Site Status COMPLETED

Novartis Investigative Site

Hamburg, , Germany

Site Status COMPLETED

Novartis Investigative Site

Heidelberg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Site Status COMPLETED

Novartis Investigative Site

Budapest, , Hungary

Site Status COMPLETED

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status COMPLETED

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Rotterdam, South Holland, Netherlands

Site Status COMPLETED

Novartis Investigative Site

Utrecht, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status COMPLETED

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Songkhla, Hat Yai, Thailand

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Argentina Austria China Denmark France Germany Hungary Japan Netherlands Spain Thailand

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Facility Contacts

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Lee Davis

Role: primary

Paul Hoffmeister

Role: primary

Other Identifiers

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2023-509318-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDRB436X2X02B

Identifier Type: -

Identifier Source: org_study_id