- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518373
Effect of G17DT in Patients With Stage II/III Colorectal Cancer (CC5)
August 5, 2015 updated by: Cancer Advances Inc.
An Open-label Volunteer Study of the Effect of G17DT on the Elevation of Plasma Gastrin Levels After Therapy With a Proton Pump Inhibitor (Omeperazole) in Patients With Treated Stage II/III Colorectal Cancer
This Phase 2 study was an open label, single-center 18-week study to compare basal and meal stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections of 250 µg G17DT, with and without the concomitant administration of Omeprazole.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects aged 18 to 70 years, inclusive
- Written informed consent was provided
- Histologically confirmed Stage II/III colorectal cancer after radical surgery
- A minimum of 3 months elapsed since completion of the chemotherapy for subjects who had received adjuvant chemotherapy
- Subject had recovered from any toxic effects of chemotherapy
Exclusion Criteria:
- Had a known local recurrence of colorectal cancer or presence of metastatic colorectal cancer lesions
- Was using an inadequate method of contraception (determined at the discretion of the investigator), only for women of childbearing potential who were sexually active
- Was unable to comply with the protocol
- Was unable to abstain from H2 receptor antagonists, PPIs or anticholinergics medications for 2 weeks
- Required H. pylori eradication therapy during the study
- Had prior vaccination with G17DT or any other product with a similar mechanism of action
- Had a history of gastric or vagus nerve surgery
- Had any clinically significant laboratory abnormalities and medical conditions which were unexplained, or, in the opinion of the investigator, did not allow for safe entry of the subject into the study
- Had contraindications to intramuscular injections (e.g., bleeding disorders or treatment with anticoagulants [except for aspirin])
- Had serious and unstable cardiovascular or respiratory disease, other malignancy or any other condition that would have jeopardized subject safety or confounded the results
- Had a known hypersensitivity to diphtheria toxoid, G17DT, any of its components or any similar compound
- Had any other condition that might have influenced the plasma gastrin level (e.g., achlorhydria, Zollinger-Ellison syndrome)
- Had used of an investigational drug within the previous month
- Had taken treatments that alter the immune response such as radiotherapy, corticosteroids, and antineoplastic drugs (Inhaled corticosteroids were permitted.)
- Had conditions that impaired the immune response (e.g., acquired immune deficiency syndrome)
- Had a history of drug or alcohol abuse within the past year
- Was unable to accept a standard breakfast for dietary reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G17DT & Omeprazole
|
G17DT is a therapeutic immunogen, formulated as a white, sterile, semi-viscous, water-in-oil emulsion (30:70 weight for weight).
It was manufactured and supplied by Nova Laboratories Ltd., in glass ampoules containing 0.5 mL at a concentration of 1.25 mg/mL, as a single dose to be administered by intramuscular injection.
Other Names:
Proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger-Ellison syndrome.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma gastrin level.
Time Frame: up to Day 100
|
Compare basal and meal stimulated plasma gastrin levels before and after treatment with three intramuscular injections of 250 µg G17DT, with and without the concomitant administration of Omeprazole.
|
up to Day 100
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
April 1, 2000
Primary Completion (Actual)
February 1, 2001
Study Completion (Actual)
February 1, 2001
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 5, 2015
First Posted (Estimate)
August 7, 2015
Study Record Updates
Last Update Posted (Estimate)
August 7, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Omeprazole
Other Study ID Numbers
- CC5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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