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A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma

NCT00998322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-04-10

No results posted yet for this study

Summary

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with gemcitabine is effective and safe in the treatment of patients with advanced pancreatic cancer.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

BIOLOGICAL

REOLYSIN

1E10 TCID50, 1-hour intravenous infusion on Days 1 and 2 and then Days 8 and 9 of a 21-day cycle.

DRUG

Gemcitabine

800 mg/m2 30-min infusion on Days 1 and 8 of a 21-day cycle.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-12-31
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00998322 on ClinicalTrials.gov