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Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer

NCT01713218 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-10-24

No results posted yet for this study

Summary

Pancreatic ductal adenocarcinoma (PDAC) has one of the worst prognoses of all human cancers and is considered as a sanctuary, resistant to most of the drugs used. Identification of new molecular targets involved in its pathogenesis is urgently needed and required both proper and innovative efficacy assessment.

This proof-of-concept trial is studying the "dynamic" tumor response after the administration of a short course (4 weeks) neoadjuvant combination of gemcitabine and a Hedgehog inhibitor (Vismodegib) before surgery in patients with operable pancreatic cancer.

Conditions

  • Pancreatic Adenocarcinoma Resectable

Interventions

DRUG

gemcitabine

Administrated intravenously at a dose of 1000 mg/m2 over 30 minutes weekly, week 1 to 4

DRUG

Vismodegib

150 mg capsule, oral, once daily

PROCEDURE

Neoadjuvant chemotherapy

Combination of gemcitabine and Vismodegib during a window interval (4 weeks) before surgery

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Jean-Luc Van Laethem

    lead OTHER

Principal Investigators

  • Jean-Luc Van Laethem, MD, PhD · Erasme University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30
Completion
2016-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT01713218 on ClinicalTrials.gov