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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Biological: G17DT

• Registration Number: NCT02181465
• 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: 1993-10
• Primary Completion: 1994-05
• Study Completion: 1994-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-03
• Last Update Submitted: 2014-07-03
• Study First Posted: 2014-07-04
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	G17DT	Three injections of G17DT with option of one booster after 16 weeks
Group 1	G17DT	One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse effects	Up to week 16

Secondary Outcome Measures

Name	Time	Method
Measure serum anti gastrin-17 antibodies to determine immunological response to medication	Up to week 16

Trial Locations

Locations (1)

University Hospital, Queen's Medical Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom