NCT02016729

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3.1 years

First QC Date

November 21, 2013

Last Update Submit

February 25, 2019

Conditions

Advanced MalignancyCancerOncologyOncology PatientsAcute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    36 months

Secondary Outcomes (1)

  • Treatment Response

    36 months

Study Arms (2)

AMG 232

EXPERIMENTAL

AMG 232 is an anti-cancer agent

Drug: AMG 232Drug: Trametinib

AMG 232 & Trametinib

EXPERIMENTAL

AMG 232 and Trametinib are anti cancer agents

Drug: Trametinib

Interventions

AMG 232DRUG

Given an an oral tablet in escalating doses.

AMG 232
TrametinibDRUG

Trametinib is an oral tablet given in a fixed dose.

AMG 232AMG 232 & Trametinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Birmingham, Alabama, 35294, United States

Location

Research Site

Buffalo, New York, 14263, United States

Location

Research Site

Charlotte, North Carolina, 28204, United States

Location

Research Site

Salt Lake City, Utah, 84112, United States

Location

Research Site

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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.

    PMID: 31253596DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsLeukemia, Myeloid, Acute

Interventions

2-(5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-(1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acidtrametinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 20, 2013

Study Start

April 1, 2014

Primary Completion

April 19, 2017

Study Completion

July 31, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(5)