Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia

November 1, 2017 updated by: Amgen

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia

This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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
    • New York
      • Stony Brook, New York, United States, 11794
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • 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 has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy
  • Must consent to undergo bone marrow biopsies per schedule of assessments

Exclusion Criteria:

  • White blood cell greater than 20,000 uL
  • History of or active central nervous system leukemia
  • Prior allogeneic bone marrow transplant
  • Subject will not be available for protocol-required study visits or procedures

Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment

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: Arm 1- Dose Escalation
The dose escalation will be conducted in 2 parts. Group 1 will consist of 8 cohorts and Group 2 will consist of 5 cohorts. The dose escalation is aimed at determining the maximum tolerated dose (MTD) of AMG 900.
Drug: Arm 1- Dose Escalation
AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
Experimental: Arm 2- Dose Expansion
The dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 20 subjects with acute myelogenous leukemia.
Drug: Arm 2- Dose Expansion
AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subject incidence of adverse events
Time Frame: 1 year
1 year
Subject incidence of dose limiting toxicities (DLTs)
Time Frame: 1 year
1 year
Maximum observed concentration of AMG 900
Time Frame: 1 year
1 year
Time to maximum observed concentration of AMG 900
Time Frame: 1 year
1 year
Area under the plasma concentration-time curve (AUC) of AMG 900
Time Frame: 1 year
1 year
Half life of AMG 900
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response as per Cheson Response Criteria
Time Frame: 1 year
1 year
Change in the number of p-Histone H3 positive cells from baseline
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Amgen

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)

October 4, 2011

Primary Completion (Actual)

September 4, 2014

Study Completion (Actual)

September 4, 2014

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101351

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.

Clinical Trials on Leukemia

Clinical Trials on Arm 1- Dose Escalation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe