Clinical trial NCT01380756: Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Hematologic Malignancies
Leukemia
Myeloid Leukemia
Keywords: Amgen
Phase 1
Clinical Trial
Aurora kinase inhibitor
Open label
Oncology
Hematology
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Subject incidence of adverse events
timeFrame: 1 year
measure: Subject incidence of dose limiting toxicities (DLTs)
timeFrame: 1 year
measure: Maximum observed concentration of AMG 900
timeFrame: 1 year
measure: Time to maximum observed concentration of AMG 900
timeFrame: 1 year
measure: Area under the plasma concentration-time curve (AUC) of AMG 900
timeFrame: 1 year
measure: Half life of AMG 900
timeFrame: 1 year
Secondary outcomes:
measure: Objective response as per Cheson Response Criteria
timeFrame: 1 year
measure: Change in the number of p-Histone H3 positive cells from baseline
timeFrame: 1 year
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.