A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
Conditions
Advanced Malignancy - Cancer - Oncology - Oncology Patients - Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: AMG 232 Type: Drug
Name: Trametinib Type: Drug
Overall Status
Recruiting
Summary
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Research Site
Birmingham, Alabama, United States
Status: Recruiting
Research Site
Buffalo, New York, United States
Status: Recruiting
Research Site
Salt Lake City, Utah, United States
Status: Recruiting
Research Site
Seattle, Washington, United States
Status: Recruiting
Start Date
April 2014
Completion Date
August 2016
Sponsors
Amgen
Source
Amgen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page