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

NCT ID: NCT02518529

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2002-12-31

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).

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

250µg dose treatment

Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.

Group Type: EXPERIMENTAL

G17DT

Intervention Type: BIOLOGICAL

Interventions

G17DT

Intervention Type: BIOLOGICAL

Other Intervention Names

Gastrimmune, Insegia, PAS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

ChapelPharma Ltd

UNKNOWN

Sponsor Role: collaborator

Cancer Advances Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

GC12

Identifier Type: -

Identifier Source: org_study_id