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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncolytics Biotech
• Collaborator: University of Texas
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• have advanced or metastatic pancreatic adenocarcinoma who have not previously received any chemotherapy or biotherapy. Patients who have received radiotherapy with or without radiotherapy enhancers (such as low dose 5-FU) will be eligible.

• have evidence of measurable disease. However, lesions in a previous radiation field are considered non-evaluable for response. Therefore, patients must have a measurable lesion that is not in a previously irradiated field to be eligible.

• have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤1. Surgery (except biopsies) must have occurred at least 28 days prior to study enrolment.

• have received NO radiotherapy within 28 days prior to receiving study drug.

• have an ECOG Performance Score ≤ 2.

• have a life expectancy of at least 3 months.

• absolute neutrophil count (ANC) ≥ 1.5 x 10^9 [SI units 10^9/L]; Platelets ≥ 100 x10^9 [SI units 10^9/L] (without platelet transfusion); Serum creatinine ≤ 1.5 x ULN; Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if patients have liver metastasis).

• negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

• no concurrent therapy with any other investigational anticancer agent while on study.

• have a history of or current evidence of brain metastasis(es).

• be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C.

• be a pregnant or breast-feeding woman.

• have clinically significant cardiac disease.

• have dementia or altered mental status that would prohibit informed consent.

• have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.