Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT02233712
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2014-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08'}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-05', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-09-05', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Levels', 'timeFrame': 'Up to Week 24', 'description': '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.'}, {'measure': 'Injection Site Reaction', 'timeFrame': 'Up to Week 12', 'description': 'An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).'}, {'measure': 'World Health Organization (WHO) Performance Status', 'timeFrame': 'Up to Week 12', 'description': 'WHO performance status was monitored up to Week 12 to compare final status with baseline status.'}, {'measure': 'Diptheria Toxoid Antibody Levels', 'timeFrame': 'Up to Week 12', 'description': 'Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to Week 24', 'description': 'Any adverse events that were reported during the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric cancer, stomach neoplasms,'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial\n* Male or female and over 18 years of age\n* Must have a life expectancy of at least three months\n* World Health Organization Performance Status of 0 to 1\n* Given written conformed consent\n\nExclusion Criteria:\n\n* Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study\n* History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix\n* Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies\n* Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids\n* Females who pregnant, planning to become pregnant or lactating\n* Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study\n* Previously received G17DT treatment\n* Haemoglobin (Hb) \\< 10.0 g/dL White blood cell count (WBC) \\< 4.0 x 10\\^9/L Platelets \\< 100 x 10\\^9/L'}, 'identificationModule': {'nctId': 'NCT02233712', 'acronym': 'GC3', 'briefTitle': 'Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cancer Advances Inc.'}, 'officialTitle': 'An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.', 'orgStudyIdInfo': {'id': 'GC3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'G17DT; 250 µg dose administered at 0, 1, and 3 weeks.', 'interventionNames': ['Biological: G17DT']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'G17DT; 100 µg dose administered at 0, 1, and 3 weeks.', 'interventionNames': ['Biological: G17DT']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'G17DT; 500 µg dose administered at 0, 1, and 3 weeks.', 'interventionNames': ['Biological: G17DT']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'G17DT; 500 µg dose administered at 0, 2, and 6 weeks.', 'interventionNames': ['Biological: G17DT']}], 'interventions': [{'name': 'G17DT', 'type': 'BIOLOGICAL', 'otherNames': ['Polyclonal Antibody Stimulator (PAS)'], 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter G McCulloch, MB, ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Aintree'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Advances Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}