Study Details

Dose escalation study to investigate the safety, tolerability and pharmacokinetics of ASP2215 in Japanese patients with relapsed or refractory acute myeloid leukemia

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02181660

Astellas Study ID

The unique identification code given by the study sponsor.

2215-CL-0102

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Leukemia - AML

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2014 - Jun 2016

Masking

None (Open Label)

Enrollment number

24

A Phase 1 Open-label, Dose-escalation Study Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP2215 in Japanese Patients with Relapsed or Refractory Acute Myeloid Leukemia

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site JP00001

Gunma, Japan

Site JP00004

Tokyo, Japan

Site JP00003

Fukuoka, Japan

Site JP00002

Aichi, Japan

Site JP00005

Tokyo, Japan