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Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

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ClinicalTrials.gov Identifier: NCT02518529
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborators:
PPD
ChapelPharma Ltd
Information provided by (Responsible Party):
Cancer Advances Inc.

Brief Summary:
Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).

Condition or disease Intervention/treatment Phase
Gastric Cancer Biological: G17DT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer
Study Start Date : February 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: 250µg dose treatment
Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.
Biological: G17DT
Other Name: Gastrimmune, Insegia, PAS




Primary Outcome Measures :
  1. Measurable Gastrin-17 Antibody Titer [ Time Frame: Up to Week 52 ]

Secondary Outcome Measures :
  1. Injection tolerability [ Time Frame: Up to Week 52 ]
    Subjects were monitored for injection site reactions and/or swelling at the injections site.

  2. Overall Survival from date of randomization to death or end of study [ Time Frame: Up to December 2002 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton.
  • Male or female patients over 18 years of age.
  • Patients with a life expectancy of at least four months.
  • Karnofsky index for performance status of >70%
  • Patients must have given written informed consent.

Exclusion Criteria:

  • Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period.
  • 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 six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy.
  • Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy.
  • Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids.
  • Known immunodeficiency.
  • 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 up to week 16 during this study.
  • Previous G17DT treatment.
  • Haematological indicators:

Haemoglobin <10.0g/dl Neutrophils < 2.0 x 109/l Platelets <100 x 109/l


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Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT02518529     History of Changes
Other Study ID Numbers: GC12
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antibodies
Gastrins
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists