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

Phase 1CompletedNCT02016729

Kartos Therapeutics, Inc.36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Malignancy Cancer Oncology Oncology Patients Acute Myeloid Leukemia

Interventions

AMG 232DRUG

Given an an oral tablet in escalating doses.

TrametinibDRUG

Trametinib is an oral tablet given in a fixed dose.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (5)

Research Site

Birmingham, Alabama, United States

Research Site

Buffalo, New York, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of AMG 232

To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.

Time frame: 36 months

Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.

PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).

Time frame: 36 months

Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.

The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in \< 33% of subjects enrolled in a cohort.

Time frame: 36 months

Secondary Outcomes

Treatment Response

Complete response (CR), complete response with incomplete recovery (CRi), and duration response.

Time frame: 36 months

Data from ClinicalTrials.gov

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