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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01380756
First received: June 9, 2011
Last updated: October 13, 2014
Last verified: October 2014
  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 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.


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: Allocation: Non-Randomized
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 Myeloid Leukemia

Resource links provided by NLM:


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 [ 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 ]

Enrollment: 35
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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: October 13, 2014
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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014