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NCT02631590 · ClinicalTrials.gov registry record · Phase 2
Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT02631590: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02631590 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02631590, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
Primary Outcome
PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this i
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Copanlisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-07-05 |
| Est. Completion | 2021-03-05 |
| Phase | Phase 2 |
What the finished NCT02631590 record still lists
NCT02631590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT02631590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02631590 about?
NCT02631590 is a clinical study titled "Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma". The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
What is the current status of trial NCT02631590?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2016-07-05. Estimated completion is 2021-03-05.
What interventions are being tested in trial NCT02631590?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT02631590?
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 NCT02631590's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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