Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Biological: G17DT; Biological: Placebo Comparator

• Registration Number: NCT02223078
• Lead Sponsor: Cancer Advances Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2001-08
• Study Completion: 2001-11
• Study First Submitted: 2014-07-02
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-22
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G17DT	G17DT	Three 250 µg injections over a six week period (weeks 0,2 and 6)
Placebo	Placebo Comparator	Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)

Primary Outcome Measures

Name	Time	Method
Antibody Levels	12 weeks	Assess effects of gastrin-17 antibodies in response to G17DT immunization.

Secondary Outcome Measures

Name	Time	Method
pharmacodynamic	12 weeks	measure production of gastrin-17 antibodies.
Number of Participants with Serious and Non-Serious Adverse Events	12 weeks	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.

Trial Locations

Locations (1)

University Hospital Aintree; 🇬🇧 Liverpool, Merseyside, United Kingdom