A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Kartos Therapeutics, Inc.
- Study ID
- NCT02016729
- Phase
- PHASE1
- Status
- Completed
Conditions
- Acute Myeloid Leukemia
- Advanced Malignancy
- Cancer
- Oncology
- Oncology Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AMG 232 — DRUGGiven an an oral tablet in escalating doses.
- Trametinib — DRUGTrametinib is an oral tablet given in a fixed dose.
Study Details
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
Key Dates
- Start date
- Apr 1, 2014
- Status verified
- Feb 2019
- Primary completion
- Apr 19, 2017
- Completion
- Jul 31, 2017
Study Design
- Enrollment
- 36 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: AMG 232AMG 232 is an anti-cancer agent
- Experimental: AMG 232 & TrametinibAMG 232 and Trametinib are anti cancer agents
Primary Outcome Measure
To evaluate the safety and tolerability of AMG 232 [ Time Frame: 36 months ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | - |
| Research Site | Buffalo | New York | 14263 | - |
| Research Site | Charlotte | North Carolina | 28204 | - |
| Research Site | Salt Lake City | Utah | 84112 | - |
| Research Site | Seattle | Washington | 98101 | - |
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