drugset / Trial / NCT01431794
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
Phase 1/2
Terminated
23 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Novartis Pharmaceuticals · collabThe Skip Viragh Foundation · collab
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-12-27
- Primary completion
- 2018-11-05
- Completion
- 2018-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sonidegib | Small molecule | 400 mg | Oral |
| Subject | Sonidegib | Small molecule | 600 mg | Oral |
| Subject | Sonidegib | Small molecule | 800 mg | Oral |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | — |