An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma (PC1)

Cancer Advances

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: G17DT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02098291

PC1

Details and patient eligibility

About

This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
• Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
• Male or female patients over 18 years of age
• Patients with a life expectancy of at least 2 months
• Patients must have given written informed consent
• Patients with a Karnofsky Performance Status score of ≥ 50%
• Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

Exclusion criteria

• History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
• Concomitant use or anticipated use in the period of the study of radiotherapy
• Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
• Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
• Females who were pregnant, planning to become pregnant or lactating
• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
• Haematological indicators:

Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

G17DT

Experimental group

Treatment:

Drug: G17DT