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

February 25, 2019 updated by: Kartos Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • New York
      • Buffalo, New York, United States, 14263
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMG 232
AMG 232 is an anti-cancer agent
Drug: AMG 232
Given an an oral tablet in escalating doses.
Drug: Trametinib
Trametinib is an oral tablet given in a fixed dose.
Experimental: AMG 232 & Trametinib
AMG 232 and Trametinib are anti cancer agents
Drug: Trametinib
Trametinib is an oral tablet given in a fixed dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
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).
36 months
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response
Time Frame: 36 months
Complete response (CR), complete response with incomplete recovery (CRi), and duration response.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartos Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 19, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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