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

Amgen

Status and phase: Completed; Phase 1

Conditions: Cancer; Myeloid Leukemia; Leukemia; Hematologic Malignancies

Treatments: Drug: Arm 1- Dose Escalation; Drug: Arm 2- Dose Expansion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01380756

20101351

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Arm 1- Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: Arm 1- Dose Escalation

Arm 2- Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: Arm 2- Dose Expansion