NCT02521649

Brief Summary

An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Sep 1998

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
14.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

May 15, 2015

Last Update Submit

August 10, 2015

Conditions

Gastric Cancer

Keywords

Gastric CancerG17DTPASInsegiaGastrimmune

Outcome Measures

Primary Outcomes (1)

  • Measurable Antibody Titer

    Up to Week 12

Secondary Outcomes (2)

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

    Up to Last Patient Last Visit, January 2001

  • Injection Site Reaction

    Through Week 12

Study Arms (5)

10µg, Stage I-III

EXPERIMENTAL

10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Drug: G17DT

100µg, Stage I-III

EXPERIMENTAL

100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Drug: G17DT

250µg, Stage I-III

EXPERIMENTAL

250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Drug: G17DT

100µg, Stage IV

EXPERIMENTAL

100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Drug: G17DT

250µg, Stage IV

EXPERIMENTAL

250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Drug: G17DT

Interventions

G17DTDRUG
Also known as: Gastrimmune, Insegia, PAS
100µg, Stage I-III100µg, Stage IV10µg, Stage I-III250µg, Stage I-III250µg, Stage IV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stage I-III Criteria-
  • Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
  • Absence of metastatic disease evident from:
  • physical examination
  • the most recent chest X-ray
  • abdominal CT or ultrasound scan
  • Life expectancy of at least 3 months
  • WHO performance status of 0 to 1
  • Written informed consent given
  • Stage IV Criteria-
  • Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
  • Life expectancy of at least 3 months
  • WHO performance status of 0 to 2
  • Written informed consent given

You may not qualify if:

  • History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
  • Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
  • Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
  • Females who were pregnant, planning to become pregnant or lactating
  • Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
  • Previous G17DT treatment
  • Haematological indicators:
  • Haemoglobin \<10.0g/dl
  • White blood cell count \<4.0 x 109/l
  • Platelets \<100 x 109/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

gastrin immunogen

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

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

Study Record Dates

First Submitted

May 15, 2015

First Posted

August 13, 2015

Study Start

September 1, 1998

Primary Completion

January 1, 2001

Study Completion

January 1, 2001

Last Updated

August 13, 2015

Record last verified: 2015-08