Clinical trial NCT02518529: Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients
Official title: An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
name: ChapelPharma Ltd
First posted: 2015-08-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measurable Gastrin-17 Antibody Titer
timeFrame: Up to Week 52
Secondary outcomes:
measure: Injection tolerability
timeFrame: Up to Week 52
measure: Overall Survival from date of randomization to death or end of study
timeFrame: Up to December 2002
Other outcomes:
Locations:
Study officials:
References: