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NCT Number: NCT01380756

Study Evaluating 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.

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Key information

Conditions

Cancer Hematologic Diseases Hematologic Malignancies Hematologic Neoplasms Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Myeloid Leukemia Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Stony Brook, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1- Dose Escalation

Drug

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 2- Dose Expansion

Drug

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 outcomes

  1. Subject incidence of adverse events

    Time frame: 1 year

  2. Subject incidence of dose limiting toxicities (DLTs)

    Time frame: 1 year

  3. Maximum observed concentration of AMG 900

    Time frame: 1 year

  4. Time to maximum observed concentration of AMG 900

    Time frame: 1 year

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

    Time frame: 1 year

  6. Half life of AMG 900

    Time frame: 1 year

Secondary outcomes

  1. Objective response as per Cheson Response Criteria

    Time frame: 1 year

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2011
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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