Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer

NCT02450032 | Completed Phase 2 DMC

• 1 other identifier: GC5
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Antibody Levels

  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.

  Through Week 12

• Injection Site Reaction

  A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.

  Up to Week 12

• Change in Subject's World Health Organization Performance Status

  The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities.

  Through Week 12

Secondary Outcomes (2)

• Overall Survival

  From date of randomization up to Week 24 or until death

• Adverse Events

  Through week 12

Study Arms (1)

G17DT

EXPERIMENTAL

Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks.

Biological: G17DT

Interventions

G17DT BIOLOGICAL

Also known as: Polyclonal Antibody Stimulator

G17DT

Eligibility Criteria

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

You may qualify if:

• Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma.
• Patients 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 patients aged 18 years or older.
• Life expectancy of at least 3 months.
• WHO Performance Status of 0 to 1.
• Written informed consent

You may not qualify if:

• Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study.
• History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix.
• Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies.
• Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids.
• Females who were pregnant, planning to become pregnant or lactating.
• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study.
• Previous G17DT treatment.
• Haematologicial indicators:
• Haemoglobin (Hb) \< 10g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L

Sponsors & Collaborators

• Cancer Advances Inc.: lead

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, G31 2 ER, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Stuart, MB ChB

  Glasgow Royal Infirmary

  PRINCIPAL INVESTIGATOR

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 27, 2014
• First Posted: May 21, 2015
• Study Start: February 1, 2000
• Primary Completion: May 1, 2001
• Study Completion: May 1, 2001
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

GB (1)