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

Kartos Therapeutics

Status and phase: Completed; Phase 1

Conditions: Oncology; Advanced Malignancy; Cancer; Oncology Patients; Acute Myeloid Leukemia

Treatments: Drug: AMG 232; Drug: Trametinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016729

20120234

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

AMG 232

Experimental group

Description:

AMG 232 is an anti-cancer agent

Treatment:

Drug: Trametinib

Drug: AMG 232

AMG 232 & Trametinib

Experimental group

Description:

AMG 232 and Trametinib are anti cancer agents

Treatment:

Drug: Trametinib