Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.

Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.

Inclusion Criteria:

• Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
• Male or female subjects over 18 years of age
• Subjects with a life expectancy of at least 2 months
• KPS score of ≥60%
• Written informed consent

Exclusion Criteria:

• Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy

• Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)

• History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix

• Known immunodeficiency

• Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)

• Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study

• Previous G17DT treatment

• Hematological indicators as follows:

  • Hemoglobin <9.5 g/dL
  • Neutrophils <2.0 × 109/L
  • Platelets <100 × 109/L

• Any other condition or circumstance that might have the following results:

  • Worsen if the subject participated in the study
  • Reduce the subject's ability to comply with the protocol
  • Confound the interpretation of the study results