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NCT01485744 · ClinicalTrials.gov registry record · Phase 1
LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01485744: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01485744 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01485744, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade of molecular events that control cell growth and have been linked with the development of many human cancers, including pancreatic cancer. Information from research studies suggests that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In this research study, the investigators are looking to determine the maximum dose of LDE225 in combination that can be given safely to patients with locally advanced or metastatic pancreatic cancer.
Primary Outcome
To determine the maximal tolerated doses of LDE225 in combination with FOLFIRINOX in patients with locally advanced or metastatic pancreatic adenocarcinoma
Interventions
- DRUG LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-12 |
| Est. Completion | 2019-11 |
| Phase | Phase 1 |
What the finished NCT01485744 record still lists
NCT01485744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan is the first listed.
NCT01485744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01485744 about?
NCT01485744 is a clinical study titled "LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer". LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade of molecular events that control cell growth and have been linked with the development of many human cancers, including pancreatic cancer. Information from research studies suggests that LDE225 in combination...
What is the current status of trial NCT01485744?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2011-12. Estimated completion is 2019-11.
What interventions are being tested in trial NCT01485744?
The interventions under investigation include: LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan (DRUG).
Who is sponsoring clinical trial NCT01485744?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01485744's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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