OncoMatch/Clinical Trials/NCT02523014
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Is NCT02523014 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Vismodegib and FAK Inhibitor GSK2256098 for intracranial meningioma.
Treatment: Vismodegib · FAK Inhibitor GSK2256098 · Capivasertib · Abemaciclib — This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Allowed: SMO mutation
Presence of SMO...mutations, as documented specifically by the central laboratory
Allowed: PTCH1 mutation
Presence of PTCH1...mutations, as documented specifically by the central laboratory
Allowed: NF2 mutation
Presence of NF2...mutations, as documented specifically by the central laboratory
Allowed: CDKN2A mutation
Presence of CDKN2A...mutations, as documented specifically by the central laboratory
Allowed: AKT1 mutation
Presence of AKT1...mutations, as documented specifically by the central laboratory
Allowed: PIK3CA mutation
Presence of PIK3CA...mutations, as documented specifically by the central laboratory
Allowed: PTEN mutation
Presence of PTEN...mutations, as documented specifically by the central laboratory
Allowed: CDKN2A copy number loss
CDKN2A copy number loss in tumor sample as documented specifically by the central laboratory
Allowed: CDK4 copy number gain
CDK4...copy number gain in tumor sample as documented specifically by the central laboratory
Allowed: CDK6 copy number gain
CDK6...copy number gain in tumor sample as documented specifically by the central laboratory
Allowed: CCND1 copy number gain
CCND1...copy number gain in tumor sample as documented specifically by the central laboratory
Allowed: CCND2 copy number gain
CCND2...copy number gain in tumor sample as documented specifically by the central laboratory
Allowed: CCND3 copy number gain
CCND3...copy number gain in tumor sample as documented specifically by the central laboratory
Allowed: CCNE1 copy number gain
CCNE1...copy number gain in tumor sample as documented specifically by the central laboratory
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
No chemotherapy, or other investigational agents within 28 days prior to registration
Cannot have received: nitrosourea
no cases of nitrosourea or mitomycin C within 6 weeks prior to registration
Cannot have received: mitomycin C
no cases of nitrosourea or mitomycin C within 6 weeks prior to registration
Cannot have received: investigational agent
No chemotherapy, or other investigational agents within 28 days prior to registration
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1,500/mm^3. Platelet count >= 100,000/mm^3. Hemoglobin >= 9 g/dL (>= 8 g/dL for abemaciclib arm).
Kidney function
Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated creatinine clearance > 50 mL/min. Urine protein:creatinine ratio (UPC) =< 45 mg/mmol.
Liver function
Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease. AST/ALT =< 2.5 x ULN.
Cardiac function
QTcF < 450 msec. Mean resting heart rate 50-100 beats per minute (BMP). Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher) as measured by echocardiogram (or MUGA scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site.
Absolute neutrophil count (ANC) >= 1,500/mm^3; Platelet count >= 100,000/mm^3; Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated creatinine clearance > 50 mL/min; Urine protein:creatinine ratio (UPC) =< 45 mg/mmol; Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease; AST/ALT =< 2.5 x ULN; Sodium, potassium, total calcium (corrected for serum albumin) & phosphorus within normal limits per institutional guidelines; QTcF < 450 msec; Mean resting heart rate 50-100 beats per minute (BMP); Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher) as measured by echocardiogram (or MUGA scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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