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NCT01431794 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01431794: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01431794 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431794, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use this treatment.
Primary Outcome
Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).
Interventions
- DRUG Gemcitabine
- DRUG nab-paclitaxel
- DRUG LDE225-600mg
- DRUG LDE225-400mg
- DRUG LDE225-800mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-12-27 |
| Est. Completion | 2018-11-05 |
| Phase | Phase 1 |
Why NCT01431794 stopped before completion
NCT01431794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Gemcitabine is the first listed.
NCT01431794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431794 about?
NCT01431794 is a clinical study titled "Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma". This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use t...
What is the current status of trial NCT01431794?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2011-12-27. Estimated completion is 2018-11-05.
What interventions are being tested in trial NCT01431794?
The interventions under investigation include: Gemcitabine (DRUG), nab-paclitaxel (DRUG), LDE225-600mg (DRUG), LDE225-400mg (DRUG), LDE225-800mg (DRUG).
Who is sponsoring clinical trial NCT01431794?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01431794's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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