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NCT02788201 · ClinicalTrials.gov registry record · Phase 2
Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma
A Phase 2 study of Bladder Cancer and Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT02788201: Completed Phase 2 study of Bladder Cancer and Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02788201 is a Phase 2 study of Bladder Cancer and Urothelial Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02788201, a Phase 2 study of Bladder Cancer and Urothelial Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment. It may also help determine which drugs fight urothelial cancer based on the characteristics of a tumor. Researchers want to test if this model can choose the best therapy for advanced urothelial cancer within 3 weeks and how tumors respond to the next best therapy. Objective: To test if the COXEN model can choose the best therapy for advanced urothelial cancer within 3 weeks. Eligibility: People ages 18 and older whose urothelial cancer has spread after at least 1 line of chemotherapy Design: Participants will be screened with medical history, physical exam, blood and urine tests, and tumor scans. Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle will remove a small piece of tumor. Participants will repeat screening tests, plus have an electrocardiogram (EKG) and scan. For the scan, they will get an injection of radioactive drug. They will lie in a machine that takes pictures. Participants will take the drugs assigned by the COXEN model. They will have visits every 2-3 weeks. These will include blood and urine tests. Participants will have tumor scans every 8-9 weeks. Participants may have another biopsy. Participants will take the drugs until they can't tolerate the side effects or their cancer worsens. They may be assigned to a second COXEN therapy. Participants will have a follow-up visit 4-5 weeks after their last drug dose. Participants will be contacted by phone every few months until death.
Primary Outcome
Participants were assigned a treatment combination by the co-expression extrapolation (COXEN) algorithm. The COXEN algorithm used a multi-step process that involved pathology, tissue processing, messenger ribonucleic acid (mRNA) profiling and bioinformatics, etc. to select a treatment regimen.
Conditions Studied
Interventions
- DRUG 75 approved agents
- OTHER COXEN
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-03-27 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 2 |
What the finished NCT02788201 record still lists
NCT02788201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which 75 approved agents is the first listed.
NCT02788201 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02788201 about?
NCT02788201 is a clinical study titled "Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma". Background: Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment. It may also help determine which drugs fight urothelial cancer based on the characteristics of a tumor...
What is the current status of trial NCT02788201?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2017-03-27. Estimated completion is 2019-10-23.
What conditions does trial NCT02788201 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT02788201?
The interventions under investigation include: 75 approved agents (DRUG), COXEN (OTHER).
Who is sponsoring clinical trial NCT02788201?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02788201 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder 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.
Where NCT02788201's enrollment target sits among peer trials
8 171st of 175 higher than 3 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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