NCT01380756

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

3 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

June 9, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 4, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2014

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2.9 years

First QC Date

June 9, 2011

Last Update Submit

November 1, 2017

Conditions

CancerHematologic MalignanciesLeukemiaMyeloid Leukemia

Keywords

AmgenPhase 1Clinical TrialAurora kinase inhibitorOpen labelOncologyHematology

Outcome Measures

Primary Outcomes (6)

  • Subject incidence of adverse events

    1 year

  • Subject incidence of dose limiting toxicities (DLTs)

    1 year

  • Maximum observed concentration of AMG 900

    1 year

  • Time to maximum observed concentration of AMG 900

    1 year

  • Area under the plasma concentration-time curve (AUC) of AMG 900

    1 year

  • Half life of AMG 900

    1 year

Secondary Outcomes (2)

  • Objective response as per Cheson Response Criteria

    1 year

  • Change in the number of p-Histone H3 positive cells from baseline

    1 year

Study Arms (2)

Arm 1- Dose Escalation

EXPERIMENTAL

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

Arm 2- Dose Expansion

EXPERIMENTAL

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

Interventions

Arm 1- Dose EscalationDRUG

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).

Arm 1- Dose Escalation
Arm 2- Dose ExpansionDRUG

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.

Arm 2- Dose Expansion

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Stony Brook, New York, 11794, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 28370201BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsHematologic NeoplasmsLeukemiaLeukemia, Myeloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic Type

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

June 9, 2011

First Posted

June 27, 2011

Study Start

October 4, 2011

Primary Completion

September 4, 2014

Study Completion

September 4, 2014

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(3)