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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380756
• Other study ID #: 20101351
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2011
• Last updated: November 1, 2017
• Start date: October 4, 2011
• Est. completion date: September 4, 2014

Study information

• Verified date: November 2017
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 4, 2014
• Est. primary completion date: September 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hematologic Malignancies
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myeloid Leukemia

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Research Site	Cleveland	Ohio
United States	Research Site	Houston	Texas
United States	Research Site	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of adverse events		1 year
Primary	Subject incidence of dose limiting toxicities (DLTs)		1 year
Primary	Maximum observed concentration of AMG 900		1 year
Primary	Time to maximum observed concentration of AMG 900		1 year
Primary	Area under the plasma concentration-time curve (AUC) of AMG 900		1 year
Primary	Half life of AMG 900		1 year
Secondary	Objective response as per Cheson Response Criteria		1 year
Secondary	Change in the number of p-Histone H3 positive cells from baseline		1 year

External Links

•   AmgenTrials clinical trials website