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

NCT02518529 | Completed Phase 2

• 1 other identifier: GC12
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Measurable Gastrin-17 Antibody Titer

  Up to Week 52

Secondary Outcomes (2)

• Injection tolerability

  Up to Week 52

• Overall Survival from date of randomization to death or end of study

  Up to December 2002

Study Arms (1)

250µg dose treatment

EXPERIMENTAL

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

Biological: G17DT

Interventions

G17DT BIOLOGICAL

Also known as: Gastrimmune, Insegia, PAS

250µg dose treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Advances Inc.: lead
• PPD Development, LP: collaborator
• ChapelPharma Ltd: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

gastrin immunogen

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 10, 2015
• Study Start: February 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: August 10, 2015

Record last verified: 2015-08