Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer (PC6)

Cancer Advances

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Biological: G17DT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02118077

PC6

Details and patient eligibility

About

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

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

154 participants in 2 patient groups, including a placebo group

G17DT

Experimental group

Description:

250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion.

Treatment:

Biological: G17DT

Placebo

Placebo Comparator group

Description:

Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.