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A Study of Enfortumab Vedotin in Japanese Subjects with Locally Advanced or Metastatic Urothelial Carcinoma

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.
NCT03070990

Astellas Study ID

The unique identification code given by the study sponsor.

7465-CL-0101

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

Follow Trial

Condition

Bladder Cancer

Phase

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

Phase 1

Age

20 years - N/A

Sex

Female & Male

Product

ASG-22CE

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

Apr 2017 - Feb 2019

Masking

None (Open Label)

Enrollment number

19

An Open-label, Randomized, Phase 1 Safety and Pharmacokinetic Study of Enfortumab Vedotin (ASG-22CE) in Japanese Patients with Locally Advanced or Metastatic Urothelial Carcinoma

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

Niigata, Japan

Site JP00002

Okayama, Japan

Site JP00008

Suita, Japan

Site JP00004

Chuo-ku, Japan

Site JP00005

Sendai, Japan

Site JP00007

Koto-ku, Japan

Site JP00003

Tsukuba, Japan

Site JP00006

Fukuoka, Japan

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