Dabrafenib and/or Trametinib Rollover Study

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03340506
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 28, 2017
Status verified
Jun 2026
Primary completion
Dec 28, 2032
Completion
Dec 28, 2032

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination [ Time Frame: 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. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-
Honor Health Research InstituteScottsdaleArizona85258
Michael Gordon (PRINCIPAL_INVESTIGATOR)
National Institute Of HealthBethesdaMaryland20892-
James Cancer Hospital and Solove Research Institute Ohio StateColumbusOhio43210-
Mary Crowley Cancer ResearchDallasTexas75251-

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Honor Health Research Institute· Scottsdale, AZNational Institute Of Health· Bethesda, MDJames Cancer Hospital and Solove Research Institute Ohio State· Columbus, OHMary Crowley Cancer Research· Dallas, TX

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