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.
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
7
sites
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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