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A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)
Full description
A Phase 1b/2, multicenter, open-label study was designed to evaluate the efficacy and safety of acalabrutinib in subjects with recurrent glioblastoma multiforme (GBM) who had progressed after one or two prior systemic treatment regimens.
Enrollment
Sex
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Volunteers
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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