An Open Label Study to Evaluate G17DT Compared to Gemcitabine

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: G17DT; Drug: Gemcitabine

• Registration Number: NCT03200821
• Lead Sponsor: Cancer Advances Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08-14
• Primary Completion: 2001-09-24
• Study Completion: 2002-09-19
• Study First Submitted: 2017-05-30
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Study First Posted: 2017-06-27
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G17DT	G17DT	250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Survival	Baseline (Week 0) up to Week 52 or death.	Survival in days measured starting at Baseline

Secondary Outcome Measures

Name	Time	Method
Tumor Response	Weeks 0, 12, 24, 36 and 52	The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST).; (RECIST) guidelines
Quality of Life	Weeks 0, 6, 12, 24, 36 and 52	Quality of life measured using and the EORTC QLQ-PAN26 questionnaire
Karnofsky Performance Status	Week 0 to Week 52	Functional impairment assessment using the Karnofsky Performance Scale Index
Gastrin-17 Antibodies	Weeks 0, 6, 12, 24, 36 and 52	Antibody assessment to determine serum levels of Gastrin -17 antibodies