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Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma
NCT02788201 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02788201
The ClinicalTrials.gov registry entry for NCT02788201 describes a study currently listed as completed. It is categorized as Phase 2, 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 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT02788201 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02788201?
The interventions under investigation include: 75 approved agents (DRUG), COXEN (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02788201?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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