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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE October 4, 2011
Actual Primary Completion Date September 4, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
  • Subject incidence of adverse events [ Time Frame: 1 year ]
  • Subject incidence of dose limiting toxicities (DLTs) [ Time Frame: 1 year ]
  • Maximum observed concentration of AMG 900 [ Time Frame: 1 year ]
  • Time to maximum observed concentration of AMG 900 [ Time Frame: 1 year ]
  • Area under the plasma concentration-time curve (AUC) of AMG 900 [ Time Frame: 1 year ]
  • Half life of AMG 900 [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • Maximum observed concentration of AMG 900 [ Time Frame: 1 year ]
  • Time to maximum observed concentration of AMG 900 [ Time Frame: 1 year ]
  • Subject incidence of adverse events [ Time Frame: 1 year ]
  • Subject incidence of dose limiting toxicities (DLTs) [ Time Frame: 1 year ]
  • Area under the plasma concentration-time curve (AUC) of AMG 900 [ Time Frame: 1 year ]
  • Half life of AMG 900 [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01380756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • Objective response as per Cheson Response Criteria [ Time Frame: 1 year ]
  • Change in the number of p-Histone H3 positive cells from baseline [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • Change in the number of p-Histone H3 positive cells from baseline [ Time Frame: 1 year ]
  • Objective response as per Cheson Response Criteria for expansion phase subjects [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
Official Title  ICMJE A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Hematologic Malignancies
  • Leukemia
  • Myeloid Leukemia
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Arm 1- Dose Escalation
  • 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.
    Intervention: Drug: Arm 2- Dose Expansion
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2014)
35
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2011)
74
Actual Study Completion Date  ICMJE September 4, 2014
Actual Primary Completion Date September 4, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01380756
Other Study ID Numbers  ICMJE 20101351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP