Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: G17DT

• Registration Number: NCT02118077
• Lead Sponsor: Cancer Advances Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2004-04
• Status Verified: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Last Update Submitted: 2014-04-17
• Study First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G17DT	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.

Primary Outcome Measures

Name	Time	Method
Patient Survival	Up to week 134	The vital status of each patient was followed until death or end of the study.
Number of Participants with Serious and Non-Serious Adverse Events	up to week 134	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.

Secondary Outcome Measures

Name	Time	Method
Objective tumor response	Weeks 24 and 52	Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.