Two Center Study to Determine Effect of G17DT on Plasma G... | NCT02223078

Studies
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.

NCT02223078

Sponsor

Cancer Advances Inc.

Status

Completed

Last Update Posted

Jun 20, 2017Actual

Enrollment

Not provided

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

G17DT
Placebo Comparator

Countries

United Kingdom

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 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2000

Primary Completion Date

Aug 2001Actual

Completion Date

Nov 2001Actual

First Submitted Date

Jul 2, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 22, 2014Estimated

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

Jun 19, 2017

Last Update Posted Date

Jun 20, 2017Actual

Description Module

Brief Summary

Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.

Detailed Description

Not provided

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

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
G17DT	Experimental	Three 250 µg injections over a six week period (weeks 0,2 and 6)	Biological: G17DT
Placebo	Placebo Comparator	Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)	Biological: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G17DT	Biological		G17DT
Placebo Comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibody Levels	Assess effects of gastrin-17 antibodies in response to G17DT immunization.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
pharmacodynamic	measure production of gastrin-17 antibodies.	12 weeks
Number of Participants with Serious and Non-Serious Adverse Events	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study.
Patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study.
Proton pump inhibitor compliance of ~70% (to be measured between screening and baseline (week 0)).
Male or female patients from 18 to 65 years of age.
Patients with a life expectancy of over three months.
World Health Organisation (WHO) Performance Status of 0 to 1.
Written informed consent given.

Exclusion Criteria:

Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose.
Patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract.
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 radiotherapy or chemotherapy.
Concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids.
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 during the study.
Previous G 17DT treatment.
Haematological indicators:

Haemoglobin <10.0 g/dL White blood cell count <4.0 x 109/L Platelets < 100 x 1 09/L

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site