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NCT01385956 · ClinicalTrials.gov registry record · Phase 1
SOM 230 and Gemcitabine in Advanced Pancreatic Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01385956: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01385956 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385956, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the study drug SOM 230 in addition to standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The safety and tolerability of different doses of SOM 230 will also be studied. The participants' physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM 230 is safe and effective.
Primary Outcome
Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug)
Interventions
- DRUG Gemcitabine
- DRUG SOM 230 LAR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01385956 record still lists
NCT01385956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01385956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385956 about?
NCT01385956 is a clinical study titled "SOM 230 and Gemcitabine in Advanced Pancreatic Cancer". The goal of this clinical research study is to learn if the study drug SOM 230 in addition to standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The safety and tolerability of different doses of SOM 230 will also be studied. The participants' physical state, changes ...
What is the current status of trial NCT01385956?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01385956?
The interventions under investigation include: Gemcitabine (DRUG), SOM 230 LAR (DRUG).
Who is sponsoring clinical trial NCT01385956?
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 NCT01385956's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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