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OpenTrials
Completed

NCT Number: NCT02181465

Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.

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–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Queen's Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically verified adenocarcinoma of the colon or rectum
  • Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
  • measurable/ evaluable lesions
  • Life expectancy > 3 months
  • Karnofsky index > 50% or WHO performance rating of 0-2
  • Biochemical markers:
  • renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
  • liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)
  • Haematological status:
  • haemoglobin, 11 g/ dl
  • WBC, 4 X 109/1
  • platelets, 100 x 109/l
  • Written consent

Exclusion criteria

  • Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
  • H 2 receptor antagonist or proton pump inhibitor therapy
  • Previous gastric surgery (including vagotomy)
  • Active uncontrolled infection
  • Autoimmune disorders
  • Anticancer treatment within the last three months unless progression of the disease occurred in the interim
  • Women of child-bearing age
  • Patient is a poor medical risk because of non-malignant systemic disease
  • Previous radiotherapy to all measurable or evaluable lesions.

Treatment and study plan

G17DT

Biological

Primary outcomes

  1. Number of participants with adverse effects

    Time frame: Up to week 16

Secondary outcomes

  1. Measure serum anti gastrin-17 antibodies to determine immunological response to medication

    Time frame: Up to week 16

Sponsors and collaborators

Lead sponsor

Cancer Advances Inc.

Industry

Registry information

Official study title

Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.

Acronym: CC1A&B

Important dates

Study start
1993
Primary completion
1994
Study completion
1994
First posted
Jul 4, 2014
Registry last updated
Jul 4, 2014

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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