NCT01380756

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

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Hematologic Malignancies
• Leukemia
• Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-10-04
• Primary completion: 2014-09-04
• Completion: 2014-09-04
• First posted: 2011-06-27
• Last updated: 2017-11-06

Locations

3 sites across 1 country: United States