A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
NCT ID: NCT02228785
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
1994-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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100µg dose of G17DT
Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
G17DT
200µg dose of G17DT
Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
G17DT
500µg dose of G17DT
Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
G17DT
Interventions
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G17DT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Cancer Advances Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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J D Hardcastle, MChir, FRCP, FRCS
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Other Identifiers
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CC1C
Identifier Type: -
Identifier Source: org_study_id