An Open Label Study to Evaluate G17DT Compared to Gemcitabine

NCT ID: NCT03200821

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-14
• Study Completion Date: 2002-09-19

Brief Summary

In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G17DT

250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.

Group Type: EXPERIMENTAL

G17DT

Intervention Type: BIOLOGICAL

250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.

Gemcitabine

1000 µg/m\^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

1000 µg/m\^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.

Interventions

G17DT

250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.

Intervention Type: BIOLOGICAL

Gemcitabine

1000 µg/m\^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.

Intervention Type: DRUG

Other Intervention Names

PAS, Polyclonal Antibody Stimulator; Gemzar

Eligibility Criteria

Inclusion Criteria

• A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
• A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
• Male or female patients over 18 years of age.
• Laboratory values within the following ranges at screening:

Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN

• A life expectancy of at least 2 months.
• A negative pregnancy test at the screening visit (females of childbearing potential only).
• Signed written informed consent.

Exclusion Criteria

• History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
• Previous cytotoxic chemotherapy (including gemcitabine).
• Previous radiotherapy within 30 days of baseline.
• Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
• Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
• Participation in another study involving an investigational drug within 90 days of baseline.

• 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

PC3

Identifier Type: -

Identifier Source: org_study_id