Dabrafenib and/or Trametinib Rollover Study

Launched by NOVARTIS PHARMACEUTICALS · Nov 8, 2017

Keywords

ClinConnect Summary

The Dabrafenib and/or Trametinib Rollover Study is a clinical trial designed to help patients who are currently benefiting from treatments with dabrafenib and/or trametinib for conditions like melanoma, lung cancer, and other solid tumors, including rare cancers and high-grade glioma. This study allows eligible patients, who are already part of a Novartis or former GSK study, to continue receiving these treatments after their original study ends. To join, patients must be currently receiving these medications and the doctor must believe that continuing the treatment will be helpful for them.

If you or a loved one is between the ages of 65 and 100 and is currently participating in a related study, you may be eligible to join this trial. Participants can expect to receive ongoing treatment with the same medications, provided they have not experienced serious side effects that led to stopping the treatment in the original study. It’s important to note that patients whose condition is already available as a standard treatment in their country may not qualify for this study. This trial is currently recruiting, so interested individuals should speak with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.