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

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ClinicalTrials.gov Identifier: NCT01380756
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : October 4, 2011
Primary Completion Date : September 4, 2014
Study Completion Date : September 4, 2014


Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01380756     History of Changes
Other Study ID Numbers: 20101351
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms