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.