NCT00998322

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

A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Oncolytics Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pancreatic cancer remains one of the most lethal cancers, ranking as the fourth leading cause of cancer death for both men and women. The American Cancer Society estimates that 37,170 men and women (18,830 men and 18,340 women) will be diagnosed with pancreatic cancer and 33,370 men and women will die of pancreatic cancer in 2008. Activating KRAS mutations are the most frequent genetic abnormalities in pancreatic cancer (occurring in 75% to 95% of patients). REOLYSIN has been demonstrated to kill a wide variety of cells with mutations along the RAS pathway, including pancreatic cancer cells. The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with gemcitabine every 3 weeks in patients with advanced pancreatic cancer. Response is a primary endpoint of this trial. Tumors will be evaluated by CT scan within 14 days of starting treatment, then at 6 weeks, and then every 6 weeks thereafter. The safety of the gemcitabine and REOLYSIN combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination. Patients may continue to receive therapy under this protocol, provided he/she has not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-12-01
• Completion: 2015-02-01
• First posted: 2009-10-20
• Last updated: 2015-04-10

Locations

2 sites across 1 country: United States