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

Status:	Active, not recruiting
Conditions:	Brain Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	7/1/2018
Start Date:	January 2016
End Date:	June 2018

A Phase 1b/2, multicenter, open-label study designed to evaluate the efficacy and safety of
ACP-196 in subjects with recurrent GBM who have progressed after 1 or 2 prior systemic
treatment regimens.

Inclusion Criteria:

- 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.

- ECOG performance status ≤ 2.

- Life expectancy ≥ 12 weeks.

- Completion of all prior anticancer therapy before first ACP-196 dose.

Exclusion Criteria:

- Three or more prior lines of systemic therapy for GBM.

- Significant cardiovascular disease.

- Evidence of bleeding diathesis or coagulopathy.

- Requires urgent palliative intervention for primary disease.

- History of stroke or clinically significant intracranial hemorrhage within 6 months
before first dose of study drug.

- Breastfeeding or pregnant.

We found this trial at

sites

Stanford Cancer Center

Palo Alto, California 94304

from

Palo Alto, CA