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
|Condition or disease||Intervention/treatment|
|Melanoma Adjuvant||Drug: Dabrafenib and Trametinib Drug: Dabrafenib Drug: Trametinib|
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|
|Official Title:||Managed Access Program (MAP) to Provide Access to Trametinib and Dabrafenib Combination Therapy in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544202
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|