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

NCT02223078 | Completed Phase 2

• 1 other identifier: CC4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Antibody Levels

  Assess effects of gastrin-17 antibodies in response to G17DT immunization.

  12 weeks

Secondary Outcomes (2)

• pharmacodynamic

  12 weeks

• Number of Participants with Serious and Non-Serious Adverse Events

  12 weeks

Study Arms (2)

G17DT

EXPERIMENTAL

Three 250 µg injections over a six week period (weeks 0,2 and 6)

Biological: G17DT

Placebo

PLACEBO COMPARATOR

Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)

Biological: Placebo Comparator

Interventions

G17DT BIOLOGICAL

G17DT

Placebo Comparator BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Advances Inc.: lead

Study Sites (1)

University Hospital Aintree

Liverpool, Merseyside, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: August 22, 2014
• Study Start: July 1, 2000
• Primary Completion: August 1, 2001
• Study Completion: November 1, 2001
• Last Updated: June 20, 2017

Record last verified: 2014-08

Locations

GB (1)