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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: Clinical Trial Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD was determined by testing planned increasing doses up to 25 mg daily dose on days 1-14, starting at 10mg. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined as any lenalidomide-related Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) Grade 3 or 4 adverse events
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Why NCT01342172 stopped before completion
NCT01342172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01342172 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01342172's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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