NCT02864290

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks \[Q3W\] or Schedule B, every other week of a 4 week cycle \[Q2W\] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of ASP1235 (AGS62P1).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	ASP1235	intravenous (IV) infusion

Timeline

• Start date: 2016-11-10
• Primary completion: 2020-09-03
• Completion: 2020-09-03
• First posted: 2016-08-12
• Last updated: 2024-10-23

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study