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Completed

NCT Number: NCT02223078

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Aintree

Liverpool, Merseyside, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G17DT

Biological

Placebo comparator

Biological

Primary outcomes

  1. Antibody Levels

    Time frame: 12 weeks

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

Secondary outcomes

  1. pharmacodynamic

    Time frame: 12 weeks

    measure production of gastrin-17 antibodies.

  2. Number of Participants with Serious and Non-Serious Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cancer Advances Inc.

Industry

Registry information

Official study 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.

Acronym: CC4

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Aug 22, 2014
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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