Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Metastatic Urothelial Cancer, sponsored by Astellas Pharma Global Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01963052 record still lists
NCT01963052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 634-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (85% lower).
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 lists 11 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Metastatic Urothelial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
RECRUITING · Phase 2
-
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
RECRUITING · Phase 2
-
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
COMPLETED · Phase 2
-
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02203526 · 93 participants · Phase 1
Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma
- NCT03089554 · 93 participants · Phase 2
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
- NCT05000021 · 93 participants · NA
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
- NCT05489887 · 93 participants · Phase 2
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI