A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | April 1, 2014 |
| End Date: | July 31, 2017 |
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute
myeloid leukemia.
myeloid leukemia.
Inclusion Criteria:
- Men or women > 18 years old
- Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory
to standard treatment, for which no standard therapy is available or the subject
refuses standard therapy
- Ability to take oral medications and willing to record daily adherance to
investigational product
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Exclusion Criteria:
- Active infection requiring intravenous (IV) antibiotics
- Prior participation in an investigational study (procedure or device) within 21 days
of study day 1
- Major surgery within 28 days of study day 1
- Anti-tumor therapy within 14 days of study day 1
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