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COMPLETED Phase 1

ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer

NCT01963052 · View on ClinicalTrials.gov ↗

Study Summary

The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for metastatic disease.

Interventions

  • DRUG AGS15E

Study Locations (11)

Ontario

  • Site CA00007 — Hamilton
  • Site CA00005 — Toronto

Alabama

  • Site US00006 — Birmingham

Connecticut

  • Site US00002 — New Haven

Michigan

  • Site US00001 — Detroit

Missouri

  • Site US00003 — St Louis

New York

  • Site US00009 — Buffalo

Pennsylvania

  • Site US00011 — Pittsburgh

Tennessee

  • Site US00010 — Nashville

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2013-11-14
Est. Completion 2019-07-08
Phase Phase 1

Sponsor

Astellas Pharma Global Development

172 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01963052

The ClinicalTrials.gov registry entry for NCT01963052 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Urothelial Cancer appearing as the primary indexed condition, and to 1 intervention — of which AGS15E is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01963052 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Ontario, Alabama, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01963052 about?

NCT01963052 is a clinical study titled "ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer". The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for metastatic disease.

What is the current status of trial NCT01963052?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2013-11-14. Estimated completion is 2019-07-08.

What conditions does trial NCT01963052 study?

This clinical trial studies the following conditions: Metastatic Urothelial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01963052?

The interventions under investigation include: AGS15E (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01963052?

This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01963052 being conducted?

This trial has 11 study locations across Alabama, Connecticut, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial