A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)

Inclusion Criteria

• - Men and women ≥18 years of age
• - Histologically confirmed GBM at first or second recurrence after concurrent
• or adjuvant chemotherapy or radiotherapy (must have received
• temozolomide).
• - Radiographic demonstration of disease progression by MRI following prior
• therapy.
• - Measurable disease (bidimensional) as defined by the RANO criteria, with a
• minimum measurement of 1 cm in longest diameter on MRI performed within
• 21 days of first dose of acalabrutinib; MRI must have been obtained ≥4
• weeks after any salvage surgery after first or second relapse.
• - Stable or decreasing dose of corticosteroids ≥5 days before baseline MRI (at
• study entry).
• - On a stable dose of any required therapy (such as anticonvulsant medication
• for subjects to be enrolled into the Phase 1b portion), for ≥3 weeks before
• the first dose of acalabrutinib.
• - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• - Life expectancy ≥ 12 weeks.
• - Completion of all prior anticancer therapy before first ACP-196 dose.
• - Need to have recovered (i.e., Grade ≤1 or baseline) from AEs associated
• with prior cancer therapy. Note: Subjects with Grade ≤2 neuropathy or Grade
• ≤2 alopecia are an exception, and may qualify for the study.