Study to Assess Tolerability and Safety and Antibody Resp... | NCT02518529

Studies
Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

NCT02518529

Sponsor

Cancer Advances Inc.

Status

Completed

Last Update Posted

Aug 10, 2015Estimated

Enrollment

41Actual

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

G17DT

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2001

Primary Completion Date

Dec 2002Actual

Completion Date

Dec 2002Actual

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2015

Last Update Posted Date

Aug 10, 2015Estimated

Name	Class
PPD Development, LP	INDUSTRY
ChapelPharma Ltd	UNKNOWN

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Label	Type	Description	Intervention Names
250µg dose treatment	Experimental	Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.	Biological: G17DT

Name	Type	Description	Arm Group Labels	Other Names
G17DT	Biological		250µg dose treatment	Gastrimmune, Insegia, PAS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurable Gastrin-17 Antibody Titer		Up to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Injection tolerability	Subjects were monitored for injection site reactions and/or swelling at the injections site.	Up to Week 52
Overall Survival from date of randomization to death or end of study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms