Clinical trial NCT03340506: Dabrafenib and/or Trametinib Rollover 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
timeFrame: 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:
measure: Clinical Benefit Assessment by investigator
timeFrame: 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.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Bethesda
country: United States
facility: National Institute Of Health
state: Maryland
city: Columbus
country: United States
facility: James Cancer Hospital and Solove Research Institute Ohio State
state: Ohio
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
state: Tyrol
city: Beijing
country: China
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
state: Zuid Holland
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Songkhla
country: Thailand
facility: Novartis Investigative Site
state: Hat Yai
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: