Trial Search Results
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)
Stanford is currently not accepting patients for this trial.
Acerta Pharma BV
- Drug: ACP-196
Phase 1/Phase 2
- 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
- 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
- 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.
- 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 been disease free for ≥2 years. Any cases of prior malignancy allowed on
study are to be approved by the study medical monitor.
- Significant cardiovascular disease.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
partial or complete bowel obstruction, or gastric restrictions and bariatric surgery,
such as gastric bypass.
- Evidence of bleeding diathesis or coagulopathy.
- Requires urgent palliative intervention for primary disease
- Requires treatment with a strong CYP3A4 inhibitor..
- History of stroke or clinically significant intracranial hemorrhage within 6 months
before first dose of study drug.
- Breastfeeding or pregnant.
- Subjects previously treated with bevacizumab (Avastin)
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study