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

Primary Purpose

Cancer, Hematologic Malignancies, Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Arm 1- Dose Escalation
Arm 2- Dose Expansion
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Amgen, Phase 1, Clinical Trial, Aurora kinase inhibitor, Open label, Oncology, Hematology

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 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1- Dose Escalation

Arm 2- Dose Expansion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response as per Cheson Response Criteria
Change in the number of p-Histone H3 positive cells from baseline

Full Information

First Posted
June 9, 2011
Last Updated
November 1, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01380756
Brief Title
Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
Official Title
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2011 (Actual)
Primary Completion Date
September 4, 2014 (Actual)
Study Completion Date
September 4, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Hematologic Malignancies, Leukemia, Myeloid Leukemia
Keywords
Amgen, Phase 1, Clinical Trial, Aurora kinase inhibitor, Open label, Oncology, Hematology

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm 1- Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2- Dose Expansion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Arm 1- Dose Escalation
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Arm 2- Dose Expansion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subject incidence of adverse events
Time Frame
1 year
Title
Subject incidence of dose limiting toxicities (DLTs)
Time Frame
1 year
Title
Maximum observed concentration of AMG 900
Time Frame
1 year
Title
Time to maximum observed concentration of AMG 900
Time Frame
1 year
Title
Area under the plasma concentration-time curve (AUC) of AMG 900
Time Frame
1 year
Title
Half life of AMG 900
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective response as per Cheson Response Criteria
Time Frame
1 year
Title
Change in the number of p-Histone H3 positive cells from baseline
Time Frame
1 year

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 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
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
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28370201
Citation
Kantarjian HM, Schuster MW, Jain N, Advani A, Jabbour E, Gamelin E, Rasmussen E, Juan G, Anderson A, Chow VF, Friberg G, Vogl FD, Sekeres MA. A phase 1 study of AMG 900, an orally administered pan-aurora kinase inhibitor, in adult patients with acute myeloid leukemia. Am J Hematol. 2017 Jul;92(7):660-667. doi: 10.1002/ajh.24736. Epub 2017 Jun 5.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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

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