An Open Label Study to Evaluate G17DT Compared to Gemcitabine

Cancer Advances

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Biological: G17DT

Study type: Interventional

Funder types: Industry

Identifiers

NCT03200821

PC3

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

G17DT

Experimental group

Description:

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

Treatment:

Biological: G17DT

Gemcitabine

Active Comparator group

Description:

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.

Treatment:

Drug: Gemcitabine