Skip to main content
OpenTrials
Completed

NCT Number: NCT02233712

Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

G17DT

Biological

Other names: Polyclonal Antibody Stimulator (PAS)

Primary outcomes

  1. Antibody Levels

    Time frame: Up to Week 24

    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.

  2. Injection Site Reaction

    Time frame: Up to Week 12

    An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).

  3. World Health Organization (WHO) Performance Status

    Time frame: Up to Week 12

    WHO performance status was monitored up to Week 12 to compare final status with baseline status.

  4. Diptheria Toxoid Antibody Levels

    Time frame: Up to Week 12

    Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.

Secondary outcomes

  1. Adverse Events

    Time frame: Up to Week 24

    Any adverse events that were reported during the study

Sponsors and collaborators

Lead sponsor

Cancer Advances Inc.

Industry

Registry information

Official study title

An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.

Acronym: GC3

Important dates

Study start
1999
Primary completion
2000
First posted
Sep 8, 2014
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.