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

Phase 1

Completed

• Conditions: Cancer; Hematologic Malignancies; Myeloid Leukemia; Leukemia
• Interventions: Drug: Arm 1- Dose Escalation; Drug: Arm 2- Dose Expansion

• Registration Number: NCT01380756
• Lead Sponsor: Amgen

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 available

Study Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Study Start: 2011-10-04
• Primary Completion: 2014-09-04
• Study Completion: 2014-09-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1- Dose Escalation	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.
Arm 2- Dose Expansion	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.

Primary Outcome Measures

Name	Time	Method
Time to maximum observed concentration of AMG 900	1 year
Subject incidence of adverse events	1 year
Subject incidence of dose limiting toxicities (DLTs)	1 year
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

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States