Dabrafenib and/or Trametinib Rollover Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 100 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

38 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Conditions

Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma

Being tested

dabrafenib, trametinib

Keywords

Tafinlar, Mekinist, Dabrafenib, Trametinib, Adult, Melanoma, Melanoma Stage IV, Metastatic Melanoma, Advanced Melanoma, Lung Cancer, NSLC, Non Small Cell Lung Cancer, BRAF V600 Mutation, BRAF Gene Mutation, Solid tumor, Rare cancers, High Grade Glioma

Medical subject headings

Melanoma, Carcinoma, Non-Small-Cell Lung, Glioma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• dabrafenibDrug

  dabrafenib is available in capsules (50mg and 75mg) taken twice a day

• trametinibDrug

  trametinib is available in tablets (0.5mg, 2mg dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination

   Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.

   Measured: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Nov 2017
2. Study start26 Jan 2018
3. Primary completion28 Dec 2032 (estimated)
4. Study completion28 Dec 2032 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for MelanomaStudies of the same condition, open and under way.
• More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.