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NCT02300610 · ClinicalTrials.gov registry record · Phase 1
Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02300610: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02300610 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02300610, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and cisplatin.
Primary Outcome
Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide. Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-02-11 |
| Est. Completion | 2019-04-19 |
| Phase | Phase 1 |
What the finished NCT02300610 record still lists
NCT02300610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT02300610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02300610 about?
NCT02300610 is a clinical study titled "Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer". The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the...
What is the current status of trial NCT02300610?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-02-11. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT02300610?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02300610?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02300610's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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