A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer

Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02228785

Acronym

CC1C

Enrollment

Registered

2014-08-29

Start date

1994-05-31

Completion date

Unknown

Last updated

2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.

Interventions

BIOLOGICALG17DT

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum. * Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy. * Life expectancy greater than 3 months. * Karnofsky Index Score greater than or equal to 50%. * Written informed consent obtained.

Exclusion criteria

* Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I. * Acute intercurrent illness. * Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results. * Patients who had received any other anticancer therapy within 3 months. * Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery. * Patients immunologically compromised including those on corticosteroid therapy. * Women of child-bearing age. * Positive immediate hypersensitivity reaction to skin testing with study medication. * Patients unable to complete the diary book * Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10\^9/L Platelet count less than 100 x 10\^9/L

Design outcomes

Primary

Measure	Time frame	Description
Injection Site Reaction	Through Week 12	An examination was performed to assess injection site tolerability at every posttreatment visit.
Antibody Levels	Through Week 12	Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.

Secondary

Measure	Time frame	Description
Intra-gastric pH	Through Week 8	Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026