Status:
COMPLETED
Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
Lead Sponsor:
Cancer Advances Inc.
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 µ...
Eligibility Criteria
Inclusion
- 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
- Male or female and over 18 years of age
- Must have a life expectancy of at least three months
- World Health Organization Performance Status of 0 to 1
- Given written conformed consent
Exclusion
- Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
- 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 last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- Females who pregnant, planning to become pregnant or lactating
- Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
- Previously received G17DT treatment
- Haemoglobin (Hb) \< 10.0 g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02233712
Start Date
August 1 1999
Last Update
September 8 2014
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