Back to resultsTwo Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer. (CC4)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
G17DT
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
- Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
- Proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
- Male or female patients from 18 to 65 years of age.
- Patients with a life expectancy of over three months.
- World Health Organisation (WHO) Performance Status of 0 to 1.
- Written informed consent given.
Exclusion Criteria:
- Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
- Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
- History of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix.
- Previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
- Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
- Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
- Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study.
- Previous G 17DT treatment.
- Haematological indicators:
Haemoglobin <10.0 g/dL White blood cell count <4.0 x 109/L Platelets < 100 x 1 09/L
Sites / Locations
- University Hospital Aintree
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
G17DT
Placebo
Arm Description
Three 250 µg injections over a six week period (weeks 0,2 and 6)
Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)
Outcomes
Primary Outcome Measures
Antibody Levels
Assess effects of gastrin-17 antibodies in response to G17DT immunization.
Secondary Outcome Measures
pharmacodynamic
measure production of gastrin-17 antibodies.
Number of Participants with Serious and Non-Serious Adverse Events
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02223078
Brief Title
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
Acronym
CC4
Official Title
Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Two Centre Study to Determine the Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
November 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
5. Study Description
Brief Summary
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
G17DT
Arm Type
Experimental
Arm Description
Three 250 µg injections over a six week period (weeks 0,2 and 6)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)
Intervention Type
Biological
Intervention Name(s)
G17DT
Intervention Type
Biological
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Antibody Levels
Description
Assess effects of gastrin-17 antibodies in response to G17DT immunization.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
pharmacodynamic
Description
measure production of gastrin-17 antibodies.
Time Frame
12 weeks
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
Proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
Male or female patients from 18 to 65 years of age.
Patients with a life expectancy of over three months.
World Health Organisation (WHO) Performance Status of 0 to 1.
Written informed consent given.
Exclusion Criteria:
Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
History of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix.
Previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy.
Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study.
Previous G 17DT treatment.
Haematological indicators:
Haemoglobin <10.0 g/dL White blood cell count <4.0 x 109/L Platelets < 100 x 1 09/L
Facility Information:
Facility Name
University Hospital Aintree
City
Liverpool
State/Province
Merseyside
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
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