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Kinase Inhibitor

Trametinib + Dabrafenib for Cancer

Phase 2

Waitlist Available

Led By Erin R Macrae

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a BRAF V600E or, V600K, V600R or V600D mutation, or another aberration, as identified via the MATCH Master Protocol

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Awards & highlights

Study Summary

This trial is testing the effects of two drugs, trametinib and dabrafenib, on patients with cancer that has a BRAF V600 mutation. Dabrafenib blocks the BRAF protein, which may be necessary for cell growth. Trametinib blocks the MEK protein, which, like the BRAF protein, may be necessary for cell growth. The researchers want to see if giving both drugs together will shrink the cancer or stop its growth.

Who is the study for?

This trial is for cancer patients with specific genetic changes called BRAF V600 mutations. They must have a normal heart rhythm, controlled blood pressure, and no severe cardiac issues. Those who've had certain antibody therapies or anticoagulants can join if they meet conditions. Excluded are those with metastatic melanoma, papillary thyroid cancer, colorectal adenocarcinoma, non-small cell lung cancer, history of lung disease or pneumonitis, known hypersensitivity to the drugs being tested or their components.Check my eligibility

What is being tested?

The trial tests Trametinib and Dabrafenib's effectiveness on cancers with BRAF V600 mutations. Trametinib blocks MEK proteins while Dabrafenib targets BRAF proteins involved in cell growth. The goal is to see if these drugs can shrink the cancers or halt their progression.See study design

What are the potential side effects?

Potential side effects include skin rash, fever, fatigue, nausea and vomiting; vision changes; heart problems; increased risk of infections; high blood pressure; bleeding events; liver problems; allergic reactions that could be severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has a specific BRAF mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dabrafenib, trametinib)Experimental Treatment2 Interventions

Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dabrafenib Mesylate

2014

Completed Phase 2

~10

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,656 Previous Clinical Trials

40,933,584 Total Patients Enrolled

Erin R MacraePrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Dabrafenib Mesylate (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439292 — Phase 2

Cancer Research Study Groups: Treatment (dabrafenib, trametinib)

Cancer Clinical Trial 2023: Dabrafenib Mesylate Highlights & Side Effects. Trial Name: NCT04439292 — Phase 2

Dabrafenib Mesylate (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439292 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other experiments been conducted on Dabrafenib Mesylate?

"At present, there are 95 ongoing trials for Dabrafenib Mesylate with 6 clinical studies in Phase 3. Though the majority of research is located in Honolulu, Hawaii; a sheer multitude of 5805 medical centres around the world are evaluating this drug."

Answered by AI

Is Dabrafenib Mesylate a sanctioned therapeutic option?

"Our assessment of Dabrafenib Mesylate's safety is a score of 2, as this is only in its second clinical trial phase and there isn't yet any data demonstrating efficacy."

Answered by AI

How many individuals have been consented to participate in this clinical trial?

"This investigation is not currently taking in volunteers. The trial was initially available on August 12th 2015, and the most recent edit being September 14th 2022. If you are seeking other trials, 4669 clinical studies for lymphoma patients are actively recruiting participants, with 95 concentrating on Dabrafenib Mesylate treatments."

Answered by AI

Is this investigation currently seeking participants?

"At present, this research is not currently accepting enrolment. Having been initially posted on August 12th 2015 and last updated 14 September 2022, it appears to be in a state of dormancy. For those seeking other trials for lymphoma, there are presently 4669 studies actively recruiting participants; 95 of these focus exclusively on Dabrafenib Mesylate-related treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)

2015. "Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439292.