Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

NCT ID: NCT02118077

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

Brief Summary

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

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

G17DT

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.

Group Type: EXPERIMENTAL

G17DT

Intervention Type: BIOLOGICAL

Placebo

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

G17DT

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Advances Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PC6

Identifier Type: -

Identifier Source: org_study_id