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Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma

NCT01431794 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-01-22

Study results available
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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.

Conditions

Interventions

DRUG

LDE225-600mg

Phase I: oral LDE225 (Sonidegib), 600mg daily. Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.

DRUG

Gemcitabine

Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.

DRUG

nab-paclitaxel

Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.

DRUG

LDE225-400mg

Phase I: oral LDE225 (Sonidegib), 400mg daily.

DRUG

LDE225-800mg

Phase I: oral LDE225 (Sonidegib), 800mg daily.

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • The Skip Viragh Foundation

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Ana De Jesus-Acosta, MD · Sidney Kimmel Comprehensive Cancer Center JHMI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-27
Primary Completion
2018-11-05
Completion
2018-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431794 on ClinicalTrials.gov