Clinical trial · Observational
A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas
A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib in BRAF-V600E Mutated Recurrent Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual and lack of funds
Summary
Brief summary (as posted)
This is a surgical biospecimen collection study. The purpose of this study is to understand how much of two drugs (dabrafenib and trametinib) are able to penetrate brain tumors and turn off the RAF signaling pathway. This is important because these drugs are currently FDA approved for other tumors and may have efficacy in brain tumors with the BRAF V600E mutation.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF V600E | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Pleomorphic Xantho-Astrocytoma | Pleomorphic Xanthoastrocytoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical Cohort | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Surgical Cohort
- description
- Blood, cerebrospinal fluid, and tumor tissue will be obtained from each participant on this arm.
- interventionNames
- Procedure: Surgical Cohort
Primary outcomes (2)
- measure
- Concentration of dabrafenib in brain tumor
- timeFrame
- Day 1
- description
- Obtain single time-point concentration of dabrafenib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample
- measure
- Concentration of trametinib in brain tumor
- timeFrame
- Day 1
- description
- Obtain single time-point concentration of trametinib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Weeks
Show eligibility criteria text
Inclusion Criteria: * Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)). * Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D. * Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician. Note: Pediatric patients may be taking any dose of dabrafenib and / or trametinib as prescribed by their treating physician for at least 7 days prior to surgery. * Subjects must be undergoing surgery for clinical purposes. * Written informed consent - a signed informed consent and/or assent (as age appropriate) for study participation will be obtained according to institutional guidelines. Exclusion Criteria: * Subjects who are receiving any other investigational agents or chemotherapeutic agents. * Subjects for whom collection of blood, spinal fluid, or tissue samples is unsafe or clinically inadvisable.
References
Publications (0)
Data not yet available