An Open Label Study To Evaluate G17DT Compared To Gemcitabine

Study Overview

An Open Label Study to Evaluate G17DT Compared to Gemcitabine

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.

N/A

Pancreatic Cancer

BIOLOGICAL: G17DT
DRUG: Gemcitabine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-05-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-06-26
First Submitted that Met QC Criteria 2017-06-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-06-27
First Posted (ACTUAL) 2017-06-27	Results First Posted N/A	Last Verified 2017-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: G17DT 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.	BIOLOGICAL: G17DT 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
ACTIVE_COMPARATOR: 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.	DRUG: 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: G17DT

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

BIOLOGICAL: G17DT

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

ACTIVE_COMPARATOR: 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.

DRUG: 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	Measure Description	Time Frame
Survival	Survival in days measured starting at Baseline	Baseline (Week 0) up to Week 52 or death.

Secondary Outcome Measures	Measure Description	Time Frame
Tumor Response	The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST). (RECIST) guidelines	Weeks 0, 12, 24, 36 and 52
Quality of Life	Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire	Weeks 0, 6, 12, 24, 36 and 52
Quality of Life	Quality of life measured using and the EORTC QLQ-PAN26 questionnaire	Weeks 0, 6, 12, 24, 36 and 52
Karnofsky Performance Status	Functional impairment assessment using the Karnofsky Performance Scale Index	Week 0 to Week 52
Gastrin-17 Antibodies	Antibody assessment to determine serum levels of Gastrin -17 antibodies	Weeks 0, 6, 12, 24, 36 and 52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record