Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

NCT02118077 | Completed Phase 3

• 1 other identifier: PC6
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Patient Survival

  The vital status of each patient was followed until death or end of the study.

  Up to week 134

• 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

Secondary Outcomes (1)

• Objective tumor response

  Weeks 24 and 52

Study Arms (2)

G17DT

EXPERIMENTAL

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.

Biological: G17DT

Placebo

PLACEBO COMPARATOR

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

Interventions

G17DT BIOLOGICAL

G17DT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Advances Inc.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2001
• Primary Completion: April 1, 2004
• Last Updated: April 21, 2014

Record last verified: 2014-04