NCT02233712

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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

August 27, 2014

Last Update Submit

September 5, 2014

Conditions

Gastric Cancer

Keywords

gastric cancer, stomach neoplasms,

Outcome Measures

Primary Outcomes (4)

  • 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.

    Up to Week 24

  • Injection Site Reaction

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

    Up to Week 12

  • World Health Organization (WHO) Performance Status

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

    Up to Week 12

  • Diptheria Toxoid Antibody Levels

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

    Up to Week 12

Secondary Outcomes (1)

  • Adverse Events

    Up to Week 24

Study Arms (4)

Group 1

EXPERIMENTAL

G17DT; 250 µg dose administered at 0, 1, and 3 weeks.

Biological: G17DT

Group 2

EXPERIMENTAL

G17DT; 100 µg dose administered at 0, 1, and 3 weeks.

Biological: G17DT

Group 3

EXPERIMENTAL

G17DT; 500 µg dose administered at 0, 1, and 3 weeks.

Biological: G17DT

Group 4

EXPERIMENTAL

G17DT; 500 µg dose administered at 0, 2, and 6 weeks.

Biological: G17DT

Interventions

G17DTBIOLOGICAL
Also known as: Polyclonal Antibody Stimulator (PAS)
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Peter G McCulloch, MB, ChB

    University Hospital Aintree

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 27, 2014

First Posted

September 8, 2014

Study Start

August 1, 1999

Primary Completion

March 1, 2000

Last Updated

September 8, 2014

Record last verified: 2014-09