Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

Conditions

• Intracranial Meningioma
• NF2 Gene Mutation
• Recurrent Meningioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vismodegib — DRUG
  Given PO
• FAK Inhibitor GSK2256098 — DRUG
  Given PO
• Capivasertib — DRUG
  Given PO
• Abemaciclib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Sep 28, 2015

Status verified

Jun 2026

Primary completion

Jan 1, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

124 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (vismodegib)
  Patients receive vismodegib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018)
• Experimental: Arm B (FAK inhibitor GSK2256098)
  Patients receive FAK inhibitor GSK2256098 PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017)
• Experimental: Arm C (capivasertib)
  Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm D (abemaciclib)
  Patients receive abemaciclib PO Q12H. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: At 6 months ]

Central Contacts

• Priscilla Brastianos, MD
  617-643-1939

Locations (780)