Dabrafenib and/or Trametinib Rollover Study

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340506
• Other study ID #: CDRB436X2X02B
• Status: Recruiting
• Phase: Phase 4
• Start date: December 28, 2017
• Est. completion date: December 21, 2027

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: Novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 21, 2027
• Est. primary completion date: December 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• High Grade Glioma
• Lung Neoplasms
• Melanoma
• Non Small Cell Lung Cancer
• Rare Cancers
• Solid Tumor

Intervention

Drug:
• dabrafenib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
• trametinib
trametinib is available in tablets (0.5mg, 2mg dose)

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Austria	Novartis Investigative Site	Innsbruck
China	Novartis Investigative Site	Beijing
Denmark	Novartis Investigative Site	Copenhagen
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Villejuif
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Mannheim	Baden Wuerttemberg
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Kashiwa	Chiba
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Utrecht
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Thailand	Novartis Investigative Site	Songkla
United States	National Institute Of Health	Bethesda	Maryland
United States	James Cancer Hospital and Solove Research Institute Ohio State	Columbus	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Honor Health Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Benefit Assessment by investigator	To evaluate clinical benefit as assessed by the 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.