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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT01380756

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

11.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Oct 4, 2011

Actual Primary Completion Date :

Sep 4, 2014

Actual Study Completion Date :

Sep 4, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Subject incidence of adverse events [1 year]
Subject incidence of dose limiting toxicities (DLTs) [1 year]
Maximum observed concentration of AMG 900 [1 year]
Time to maximum observed concentration of AMG 900 [1 year]
Area under the plasma concentration-time curve (AUC) of AMG 900 [1 year]
Half life of AMG 900 [1 year]

Secondary Outcome Measures

Objective response as per Cheson Response Criteria [1 year]
Change in the number of p-Histone H3 positive cells from baseline [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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