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New treatment option for BRAF V600 Mutation
Official title Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
ClinicalTrials.gov ID: NCT07110246
What this study is testing
What is Dabrafenib?
Dabrafenib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for braf v600 mutation.
Also referred to as Dabrafenib Mesylate, GSK2118436B.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- Participants must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by...
- Participants must have measurable tumor. \ For participants with measurable disease, this will be defined as lesions that can be accurately measured...
- Cohort 1:
- Participants must have no prior therapy, except for surgical intervention (i.e. biopsy or resection)
- Participants may currently be taking dabrafenib and trametinib as frontline therapy, with a maximum duration of 21 months and participants must not...
You likely can't join if
- Participant's tumor has any of the following additional previously known or expected activating molecular alterations:
- Isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutation
- Histone H3 mutation (p.K28M, p.G35R, p.G35V)
- Neurofibromatosis Type 1 (NF-1) loss of function alteration
- Participants who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and trametinib
See the full eligibility criteria
- Participants must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by immunohistochemistry or sequencing
- Participants must have measurable tumor. \ For participants with measurable disease, this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) with a minimum...
- Cohort 1:
- Participants must have no prior therapy, except for surgical intervention (i.e. biopsy or resection)
- Participants may currently be taking dabrafenib and trametinib as frontline therapy, with a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this...
- Cohort 2: \ Participants must have a history of recurrent or progressive disease following prior therapy (e.g., carboplatin and vincristine, vinblastine, bevacizumab, mitogen-activated extracellular signal-regulated...
- Participants must have received their last dose of chemotherapy 3 weeks prior to enrollment (6 weeks for nitrosoureas) and recovered from acute adverse events due to agents administered
- Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent except dabrafenib and trametinib. For any agent with known adverse events that can occur beyond 7 days after...
- Radiation:
- No prior radiation is allowed for participants in Cohort 1
- Participants in Cohort 2 must have:
- Had their last fraction of local irradiation to primary tumor ≥ 12 weeks prior to registration
- Had their last fraction of craniospinal irradiation ≥ 12 weeks prior to registration
- At least 14 days after local palliative radiation (small-port)
- Age: ≥ 12 months and \< 25 years old
- Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be...
- Peripheral absolute neutrophil count (ANC) ≥ 1000/mm\^3
- Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
- A serum creatinine ≤ 1.5 upper limit of normal (ULN) based on age and gender
- Total bilirubin ≤ 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN
- Alanine aminotransferase (ALT) ≤ 3 x ULN
- Aspartate aminotransferase (AST) ≤ 3 x ULN
- Participants with seizure disorder may be enrolled if well controlled
- Left ventricular ejection fraction (LVEF) greater than or equal to institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function)
- Correct QT (QTc) interval \< 480 msecs
- Patient must agree to adequate contraception. (The effects of dabrafenib and trametinib on the developing human fetus are unknown. For this reason and because agents as well as other therapeutic agents used on this...
- A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate
- Participants must enroll on Pediatric Neuro-Oncology Consortium (PNOC) comprehensive follow up protocol (PNOC COMP) if PNOC COMP is open to accrual at the enrolling institution
- Pathology reports, next generation sequencing reports, or both, confirming BRAF V600E mutation status must be submitted at the time of enrollment
- Participant's tumor has any of the following additional previously known or expected activating molecular alterations:
- Isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutation
- Histone H3 mutation (p.K28M, p.G35R, p.G35V)
- Neurofibromatosis Type 1 (NF-1) loss of function alteration
- Participants who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and trametinib
- Medications that are affected by the induction of CYP3A4 and CYP2C9 should be avoided or used cautiously. Dabrafenib has been shown to induce CYP3A4 and CYP2C9. In addition, dabrafenib is an in vitro inducer of CYP2B6...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection
- Women of childbearing potential must not be pregnant or breast-feeding
- Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Memphis, Tennessee, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Durham, North Carolina, United States; Memphis, Tennessee, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.