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NCT01342172 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01342172 is a Phase 1 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 9 participants.
The verdict
NCT01342172, a Phase 1 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary objectives of this study are (Phase 1) to determine in subjects with unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to study this recommended dose in subjects to evaluate progression-free survival at 1 year. The secondary objectives will be to determine the objective response rate to treatment, and the safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to evaluate lenalidomide as maintenance treatment in subjects achieving objective response or stable disease.
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01342172
The ClinicalTrials.gov registry entry for NCT01342172 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01342172 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01342172 about?
NCT01342172 is a clinical study titled "Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma". The primary objectives of this study are (Phase 1) to determine in subjects with unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to study this recommende...
What is the current status of trial NCT01342172?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-03. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01342172?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01342172?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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