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Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection

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ClinicalTrials.gov Identifier: NCT04544202
Expanded Access Status : Available
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date September 3, 2020
First Posted Date September 10, 2020
Last Update Posted Date September 10, 2020
 
Descriptive Information
Brief Title Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
Brief Summary The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
Detailed Description

The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication.

This program will provide access to patients until:

  • All participating countries have received marketing authorization and product is commercially available and accessible to all participating patient(s) or
  • Alternative treatment options are available and/or
  • In case of changes in the safety profile or a lack of overall efficacy of the product.
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention
  • Drug: Dabrafenib and Trametinib

    The starting dose of the combination treatment will be administered as follows:

    • Dabrafenib, 150 mg, twice daily (BID);
    • Trametinib, 2.0 mg, once daily (QD)
  • Drug: Dabrafenib
    If administration of dabrafenib is interrupted or permanently discontinued, administration of trametinib may continue.
  • Drug: Trametinib
    If administration of trametinib is interrupted or permanently discontinued, administration of dabrafenib may be continued.
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
Expanded Access Status Available
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04544202
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Investigators Not Provided
PRS Account Novartis
Verification Date September 2020