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NCT02612194 · ClinicalTrials.gov registry record · Phase 2
LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02612194 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 8 participants.
The verdict
NCT02612194, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a single arm two-stage phase II study with crizotinib (Xalkori®) in the treatment of subjects with metastatic urothelial cancer of the bladder, upper (ureter or renal pelvis) or lower (urethra) urinary tracts. The purpose of this study is to see if this experimental drug has a potential benefit in subjects with stage 4 urothelial cancer. This study tests crizotinib used alone in subjects with urothelial cancer, previously treated with chemotherapy, and whose tumors have certain proteins. Proteins are complex natural substances essential to the structure and function of all living cells. These proteins, c-MET or RON, may trigger molecular pathways that are involved in the growth and spread of bladder or upper urinary tract cancer. Crizotinib is a drug taken by mouth that blocks these pathways. Early laboratory research suggests that crizotinib may benefit patients with urothelial and other cancers with these molecular pathways.
Interventions
- DRUG Crizotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-09-27 |
| Est. Completion | 2019-11-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02612194
The ClinicalTrials.gov registry entry for NCT02612194 describes a study currently listed as terminated, categorized as Phase 2. 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 Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Crizotinib is the first listed.
NCT02612194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02612194 about?
NCT02612194 is a clinical study titled "LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer". This is a single arm two-stage phase II study with crizotinib (Xalkori®) in the treatment of subjects with metastatic urothelial cancer of the bladder, upper (ureter or renal pelvis) or lower (urethra) urinary tracts. The purpose of this study is to see if this experimental drug has a potential bene...
What is the current status of trial NCT02612194?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2016-09-27. Estimated completion is 2019-11-21.
What interventions are being tested in trial NCT02612194?
The interventions under investigation include: Crizotinib (DRUG).
Who is sponsoring clinical trial NCT02612194?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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