Single Centre Study to Determine the Antibody Response to... | NCT02098239

Studies
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

NCT02098239

Sponsor

Cancer Advances Inc.

Status

Completed

Last Update Posted

Mar 27, 2014Estimated

Enrollment

41Actual

Phase

Phase 2

Conditions

Jaundice
Pancreatic 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

Mar 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

Aug 1999

Primary Completion Date

Apr 2002Actual

Completion Date

May 2002

First Submitted Date

Mar 25, 2014

First Submission Date that Met QC Criteria

Mar 25, 2014

First Posted Date

Mar 27, 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

Mar 25, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Description Module

Brief Summary

The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Detailed Description

Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.	Drug: G17DT
Group B	Active Comparator	Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.	Drug: G17DT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G17DT	Drug		Group A Group B	Polyclonal Antibody Stimulator (PAS)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacodynamic	Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.	Weeks 0, 1,3,4,6,8,12, 16+
Patient Survival	The vital status of patients was monitored throughout the study and was followed until death or the end of the study.	Up to week 139

Secondary Outcomes

Measure	Description	Time Frame
Injection Tolerability	Tolerability was assessed by injection site during first 16 weeks after the first injection.	Up to Week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
If patients were jaundiced, bilirubin had to be >80 μmol/L.
Male or female patients over 18 years of age.
World Health Organization (WHO) performance status of 0 to 2.
Patients with a life expectancy of at least 8 weeks.
Patients must have given written informed consent.

Exclusion Criteria:

Patients undergoing a potentially curative resection.
Jaundiced patients with a bilirubin value <80 μmol/L.
Patients not considered fit for endoscopic or percutaneous biliary stenting.
Patients receiving any other anti-cancer therapy.
History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
Females who were pregnant, planning to become pregnant, or who were lactating.
Patients 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 (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/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

Condition Browse Module

MeSH Terms

ID	Term
D007565	Jaundice
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D006932	Hyperbilirubinemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012877	Skin Manifestations

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