Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PC6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118077
• Other study ID #: PC6
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2014
• Last updated: April 17, 2014
• Start date: April 2001

Study information

• Verified date: April 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• G17DT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Survival	The vital status of each patient was followed until death or end of the study.	Up to week 134	Yes
Primary	Number of Participants with Serious and Non-Serious Adverse Events	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.	up to week 134	Yes
Secondary	Objective tumor response	Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.	Weeks 24 and 52	Yes