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Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Leukemias and Related Disorders

This study is currently recruiting participants.
Verified August 2012 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01380756
First received: June 9, 2011
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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 leukemias and related disorders. Up to 54 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.


Condition Intervention Phase
Cancer
Hematologic Malignancies
Leukemia
Myeloid Leukemia
 Drug: Arm 1- Dose Escalation
Drug: Arm 2- Dose Expansion
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Leukemias and Related Disorders

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Subject incidence of dose limiting toxicities (DLTs) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Maximum observed concentration of AMG 900 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to maximum observed concentration of AMG 900 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve (AUC) of AMG 900 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Half life of AMG 900 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response as per Cheson Response Criteria for expansion phase subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in the number of p-Histone H3 positive cells from baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1- Dose Escalation
The dose escalation part of the study will consist of 6 cohorts and is 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 (i.e., 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. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women ≥ 18 years old
  • Part 1 - Dose Escalation only: Pathologically documented, definitively diagnosed, leukemia or related disorder that has failed standard treatment, for which no standard therapy is available. Patients with myelodysplasia (MDS), chronic myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) are eligible for Part 1 of this study Part 2 - Dose Expansion only: Pathologically documented, definitively diagnosed, acute myeloid leukemia that has failed standard treatment, for which no standard therapy is available.
  • 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380756

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, New York
Research Site Recruiting
Stony Brook, New York, United States, 11794
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01380756     History of Changes
Other Study ID Numbers: 20101351
Study First Received: June 9, 2011
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Amgen
Phase 1
Clinical Trial
Aurora kinase inhibitor
 Open label
Oncology
Hematology

Additional relevant MeSH terms:
Neoplasms
Leukemia
Leukemia, Myeloid
Hematologic Neoplasms
 Neoplasms by Histologic Type
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013