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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
Study Summary
This trial will study the effects of a drug on people with cancer, including brain tumors, to see if it improves their condition.
Who is the study for?
This trial is for individuals aged 10 and older, weighing at least 30 kg, with certain types of advanced or recurrent cancer that have specific BRAF gene changes. They must have tried standard treatments or be unsuitable for them and should provide tissue samples for testing. People who've had prior MEK inhibitors or have uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of FORE8394 in patients with solid tumors or CNS tumors having BRAF alterations, as well as those with high-grade glioma (HGG) harboring a BRAF V600E mutation. It's an open-label trial divided into two parts based on different genetic mutations.See study design
What are the potential side effects?
While not explicitly listed in the provided information, side effects may include typical reactions to cancer medications such as nausea, fatigue, skin reactions, gastrointestinal issues and potential drug interactions especially related to cobicistat.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
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
DOR per Investigator Assessment
Disease Control Rate (DCR)
Duration of Response (DOR)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
Participants with recurrent primary CNS tumors harboring BRAF V600E mutations will receive 900 mg of plixorafenib administered with 150 mg of cobicistat QD, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
Group II: Group AExperimental Treatment2 Interventions
Participants with unresectable, locally advanced or metastatic solid tumors or primary CNS tumors harboring BRAF fusions, will receive 900 mg of plixorafenib administered with 150 mg of cobicistat once daily (QD), continuously in 3-weeks cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobicistat
2014
Completed Phase 2
~640
Find a Location
Who is running the clinical trial?
Fore BiotherapeuticsLead Sponsor
6 Previous Clinical Trials
215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have NF1 or RAS-related mutations.My cancer shows signs of changes due to past treatments, not because of a main mutation.I have been diagnosed with a solid or primary brain tumor.I can provide a recent tissue sample for the study, or I've never had targeted therapy if my sample is older.I can provide a tissue sample for testing, either previously stored or newly taken.My cancer has a BRAF gene fusion confirmed by a specific test.I have a high-grade glioma or my grade 2 glioma has progressed to a higher grade.I am taking or plan to take drugs that strongly affect liver enzyme CYP3A4 or can't be taken with cobicistat.I have tried or cannot tolerate standard treatments, or my doctor thinks they're not suitable for me.I am at least 10 years old and weigh more than 30 kg.I am at least 10 years old and weigh 30 kg or more.I am taking or plan to take drugs that strongly affect CYP3A4 enzyme activity, excluding cobicistat.My cancer has a BRAF V600E mutation confirmed by a specific test.My side effects from previous treatments are mild or gone, except for possible hair loss or mild nerve issues.My side effects from previous treatments are mild or gone, except for possible hair loss or mild nerve pain.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety protocols are observed when using Group A with patients?
"Our team has determined that Group A's safety is likely a 2 on the 1-3 scale due to their Phase 2 designation. This means there are some data points indicating security, but none confirming efficacy."
Answered by AI
What is the enrollment capacity for this research project?
"This clinical trial requires 135 qualified participants. Nebraska Cancer Specialists - Midwest Cancer Center - Legacy in Omaha, NE and Toledo Clinic Cancer Center in Toledo, OH are two of the potential sites where individuals can join the study."
Answered by AI
Are there any available enrolments left in this research?
"Affirmative. According to the clinicaltrials.gov information, this study is open for recruitment and was first announced on March 1st 2023 with updates made as recently as February 10th 2023. A total of 135 participants are needed from 3 different sites."
Answered by AI
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