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. Exclusion Criteria: * Three or more prior lines of systemic therapy for GBM. * Prior malignancy (other than GBM), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has bee…