Skip to main content
OpenTrials
Completed

NCT Number: NCT02016729

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Malignancy Acute Myeloid Leukemia Cancer Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Oncology Oncology Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 232

Drug

Given an an oral tablet in escalating doses.

Trametinib

Drug

Trametinib is an oral tablet given in a fixed dose.

Primary outcomes

  1. To evaluate the safety and tolerability of AMG 232

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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 outcomes

  1. Treatment Response

    Time frame: 36 months

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

Sponsors and collaborators

Lead sponsor

Kartos Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2013
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.