A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population
United States: Food and Drug Administration
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Cancer Therapy & Research Center at UTHSCSA||San Antonio, Texas 78229|