A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2017-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Kartos Therapeutics, Inc.
• Treatments: Trametinib

Criteria

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