Safety and Efficacy of G17DT Immunogen Combined With Gemc... | NCT00044031

Studies
Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

NCT00044031

Sponsor

Cancer Advances Inc.

Status

Completed

Last Update Posted

Apr 17, 2014Estimated

Enrollment

394Actual

Phase

Phase 3

Conditions

Pancreatic Cancer

Interventions

G17DT Immunogen

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

Official Title

Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)

Status Module

Record Verification Date

Apr 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

Yes

Start Date

Feb 2001

Primary Completion Date

Apr 2004Actual

Completion Date

Oct 2007Actual

First Submitted Date

Aug 16, 2002

First Submission Date that Met QC Criteria

Aug 19, 2002

First Posted Date

Aug 20, 2002Estimated

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

Apr 16, 2014

Last Update Posted Date

Apr 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

394Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Placebo Comparator	Placebo (immunogen vehicle) combined with gemcitabine.
A	Experimental	500 µg G17DT immunogen combined with gemcitabine.	Biological: G17DT Immunogen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G17DT Immunogen	Biological		A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival		Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
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.	Up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
Life expectancy of at least 3 months
Functional status by Karnofsky Index of at least 70

Exclusion criteria:

Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
Immunodeficiency
Bone marrow transplant within past year
Brain metastasis

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
R Hawkins, M.D.	Christie Hospital, Manchester	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C482698	gastrin immunogen

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided