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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01431794
The ClinicalTrials.gov registry entry for NCT01431794 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Gemcitabine is the first listed.
NCT01431794 reports 0 study locations.
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.
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