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

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