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Dabrafenib and/or Trametinib Rollover Study

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ClinicalTrials.gov Identifier: NCT03340506
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 8, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date May 27, 2021
Actual Study Start Date  ICMJE December 28, 2017
Estimated Primary Completion Date May 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination [ Time Frame: Baseline up to approximately 5 years ]
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, require concomitant therapy or require changes in treatment constitute an adverse event.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
Clinical Benefit Assessment by investigator [ 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. ]
To evaluate clinical benefit as assessed by the Investigator
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Clinical Benefit Assessment by investigator [ Time Frame: Baseline up to approximately 5 years ]
To evaluate clinical benefit as assessed by the Investigator
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dabrafenib and/or Trametinib Rollover Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Non Small Cell Lung Cancer
  • Solid Tumor
  • Rare Cancers
  • High Grade Glioma
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: dabrafenib monotherapy

    Patients in this study may receive:

    - monotherapy of dabrafenib

    Intervention: Drug: dabrafenib
  • Experimental: trametinib monotherapy

    Patients in this study may receive:

    - monotherapy of trametinib

    Intervention: Drug: trametinib
  • Experimental: Combination therapy (dabrafenib & trametinib)

    Patients in this study may receive:

    - the combination of dabrafenib and trametinib

    Interventions:
    • Drug: dabrafenib
    • Drug: trametinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2023
Estimated Primary Completion Date May 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Argentina,   China,   France,   Hungary,   Spain,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03340506
Other Study ID Numbers  ICMJE CDRB436X2X02B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP