Plixorafenib for Cancers with BRAF Alterations
This study is testing a drug called plixorafenib in people with cancer that has specific changes in the BRAF gene (BRAF V600E or BRAF fusions). This includes advanced solid tumors or brain and spinal cord tumors. The study aims to see how well plixorafenib works to shrink tumors and if it is safe. To join, you must be at least 8 years old and weigh at least 25 kg, and your tumor must have a BRAF gene alteration. The study plans to enroll 254 participants, but its current status is unclear. Researchers will measure how many people respond to the treatment over about four years.
- Study design
- This interventional study is evaluating plixorafenib in 254 planned participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure how well the treatment works and how the drug moves through the body for up to approximately 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
At a glance
Conditions
Where it's being run
70 sites across 54 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Objective Response Rate (ORR) (Subprotocols A, B and C)Up to approximately 4 years
ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).
- Pharmacokinetics (Subprotocol D)Up to approximately 4 years
Systemic exposure of plixorafenib measured by Cmax and AUC