Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610682
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Feasibility of CSF and Plasma ctDNA in BRAF-altered Glioma During Treatment With Plixorafenib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of CSF Cerebrospinal Fluid and Plasma ctDNA Circulating Tumor Deoxyribonucleic in BRAF V-raf Murine Sarcoma Viral Oncogene Homolog B1-Altered Glioma During Treatment With Plixorafenib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluating the sensitivity and feasibility of using ctDNA assays optimized for detecting very low ctDNA counts from cerebrospinal fluid CSF and plasma The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline defined as Cycle1 Day1 C1D1 pre-treatment and over time in response to treatment with plixorafenib co-administered with cobicistat in BRAF-V600E mutant glioma refractory to prior therapies
Detailed Description:
This clinical trial is designed as a pilot signal-finding study to demonstrate the feasibility of detecting ctDNA at baseline and after 4 weeks of treatment primary endpoint as well as correlating with disease status as per radiographic response RR secondary endpoint In addition the investigators will generate preliminary data for activity of plixorafenib co-administered with cobicistat in this heavily-pretreated population Patients with measurable by Response Assessment in Neuro-Oncology RANO 20 recurrent BRAF-V600E mutant glioma will be screened and consented for the study prior to surgery Patients will undergo pre-operative MRI and clinically-indicated resection or biopsy specific approach as per treating neurosurgeon for confirmation of progression and characterization of potential acquired resistance alterations All patients will have a ventricular reservoir placed at time of surgery with CSF and plasma sampling Patients will start the study drug plixorafenib 900mg daily co-administered with cobicistat 150mg daily 7-28 days post-operatively when clinically stable Patients will take the drug daily by mouth under fasting conditions continuously for 28-day cycles until progressive disease or up to 24 cycles MRI will be performed post-operatively between proof of delivery POD0 and start of study drug for evaluation of measurable disease after Cycle 1 then every 2 cycles Blood and CSF samples will be obtained on day of surgery at baseline pre-C2 then with each MRI A total of 12 evaluable patients will be enrolled Patients who do not start drug will be replaced up to a total of 15 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None