Dabrafenib + Trametinib for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+41 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests two drugs, dabrafenib and trametinib, on adults with a specific type of advanced thyroid cancer. These patients have a genetic mutation and have not responded to other treatments. The drugs work by blocking proteins that help cancer cells grow.

Research Team

Eligibility Criteria

Adults over 18 with advanced thyroid cancer that's not responding to radioactive iodine and has a specific mutation (BRAFV600E) can join. They must have tried at least one but no more than two prior therapies targeting VEGFR, be in decent physical condition, and have at least one tumor that can be measured. People who've had certain other cancers or treatments recently, or those with eye disease risks, cannot participate.

Inclusion Criteria

I am 18 years old or older.

My tumor has the BRAFV600E mutation.

Signed informed consent must be obtained prior to performing any specific pre-screening and screening procedure

Exclusion Criteria

I have been treated with BRAF or MEK inhibitors before.

My thyroid cancer is RET fusion positive.

I haven't had cancer treatment with antibodies or chemotherapy in the last 4 weeks.

Treatment Details

Interventions

• Dabrafenib (Kinase Inhibitor)
• Trametinib (Kinase Inhibitor)

Trial Overview The trial is testing the effectiveness of combining Dabrafenib and Trametinib against placebos in patients whose thyroid cancer has worsened despite previous treatment. Participants will be randomly assigned to either the drug combo or placebo group in a 2:1 ratio based on their past treatments.

Participant Groups

Group I: Dabrafenib plus trametinib Experimental Treatment 2 Interventions

Participants will be treated with dabrafenib twice daily and trametinib once daily

Group II: Placebo dabrafenib plus placebo trametinib Placebo Group 2 Interventions

Participants will receive placebo dabrafenib twice daily and placebo trametinib once daily

Dabrafenib is already approved in Canada, Japan for the following indications:

Approved in Canada as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation
• Adjuvant treatment of melanoma with a BRAF V600 mutation

Approved in Japan as Tafinlar for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

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