Dabrafenib + Trametinib Access for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing treatment with dabrafenib and/or trametinib for those already on these medications.
Is the combination of Dabrafenib and Trametinib safe for humans?
The combination of Dabrafenib and Trametinib has been shown to be generally safe in humans, with most side effects being mild or moderate and manageable. Common side effects include fever, increased liver enzymes, swelling, and cold-like symptoms, but the combination therapy tends to have fewer skin-related side effects compared to Dabrafenib alone.12345
How is the drug combination of Dabrafenib and Trametinib unique for treating cancer?
The combination of Dabrafenib and Trametinib is unique because it targets the MAPK pathway by inhibiting both BRAF and MEK proteins, which helps in treating cancers with BRAF mutations, like melanoma, more effectively than using either drug alone. This combination has shown to improve survival rates and reduce skin-related side effects compared to other treatments.12367
What data supports the effectiveness of the drug combination Dabrafenib and Trametinib for cancer treatment?
Research shows that the combination of Dabrafenib and Trametinib is effective in treating advanced melanoma with a specific BRAF mutation, leading to longer survival and better response rates compared to using each drug alone. This combination also shows promise in patients with brain metastases and is generally well tolerated.128910
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for patients already taking dabrafenib and/or trametinib in a Novartis or former GSK study, who have met the main goals of that study and are seen by their doctor as benefiting from ongoing treatment. It's not open to those who've had to stop these drugs due to side effects or if the drugs are available commercially with reimbursement in their country.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dabrafenib and/or trametinib as monotherapy or combination therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive treatment until it becomes commercially available or another access program is available
What Are the Treatments Tested in This Trial?
Interventions
- Dabrafenib
- Trametinib
Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600E mutation
- Adjuvant treatment of melanoma with a BRAF V600E or V600K mutation
- Metastatic non-small cell lung cancer with a BRAF V600E mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD