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

Primary Purpose

Advanced Malignancy, Cancer, Oncology

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 232
Trametinib
Sponsored by
Kartos Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignancy focused on measuring AML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AMG 232

AMG 232 & Trametinib

Arm Description

AMG 232 is an anti-cancer agent

AMG 232 and Trametinib are anti cancer agents

Outcomes

Primary Outcome Measures

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.
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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2013
Last Updated
February 25, 2019
Sponsor
Kartos Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02016729
Brief Title
A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
April 19, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kartos Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignancy, Cancer, Oncology, Oncology Patients, Acute Myeloid Leukemia
Keywords
AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG 232
Arm Type
Experimental
Arm Description
AMG 232 is an anti-cancer agent
Arm Title
AMG 232 & Trametinib
Arm Type
Experimental
Arm Description
AMG 232 and Trametinib are anti cancer agents
Intervention Type
Drug
Intervention Name(s)
AMG 232
Intervention Description
Given an an oral tablet in escalating doses.
Intervention Type
Drug
Intervention Name(s)
Trametinib
Intervention Description
Trametinib is an oral tablet given in a fixed dose.
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of AMG 232
Description
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
Title
Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.
Description
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
Title
Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.
Description
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 Outcome Measure Information:
Title
Treatment Response
Description
Complete response (CR), complete response with incomplete recovery (CRi), and duration response.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31253596
Citation
Erba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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