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NCT01963052 · ClinicalTrials.gov registry record · Phase 1
ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer
A Phase 1 study of Metastatic Urothelial Cancer, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 11
- Study locations
NCT01963052 is a Phase 1 study of Metastatic Urothelial Cancer that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 93 participants, below the 634-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (85% lower). The trial reports 11 study locations across 10 states.
The verdict
NCT01963052, a Phase 1 study of Metastatic Urothelial Cancer, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 11
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2013-11-14 |
| Est. Completion | 2019-07-08 |
| Phase | Phase 1 |
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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, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 634-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
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.
NCT01963052 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Ontario, Alabama, Connecticut.
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.
What interventions are being tested in trial NCT01963052?
The interventions under investigation include: AGS15E (DRUG).
Who is sponsoring clinical trial NCT01963052?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.