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

Phase 1

Completed

• Conditions: Advanced Malignancy; Cancer; Oncology; Oncology Patients; Acute Myeloid Leukemia
• Interventions: Drug: AMG 232; Drug: Trametinib

• Registration Number: NCT02016729
• Lead Sponsor: Kartos Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Study Start: 2014-04-01
• Primary Completion: 2017-04-19
• Study Completion: 2017-07-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 232	AMG 232	AMG 232 is an anti-cancer agent
AMG 232 & Trametinib	Trametinib	AMG 232 and Trametinib are anti cancer agents
AMG 232	Trametinib	AMG 232 is an anti-cancer agent

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of AMG 232	36 months	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.
Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.	36 months	PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.	36 months	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Response	36 months	Complete response (CR), complete response with incomplete recovery (CRi), and duration response.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States