S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Pat... | NCT00602745

ID	Type	Description	Link
S-1 - FI

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 16, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 28, 2008Estimated

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

Apr 27, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 27, 2016

Certification/Extension First Posted Date

May 26, 2016Estimated

Last Update Submitted Date

Apr 27, 2016

Last Update Posted Date

May 26, 2016Estimated

Name	Class
Taiho Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

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

61Actual

Label	Type	Description	Intervention Names
5-Fluorouracil	Active Comparator		Drug: 5-Fluorouracil
S-1	Experimental		Drug: S-1

Name	Type	Description	Arm Group Labels	Other Names
S-1	Drug	oral administration	S-1
5-Fluorouracil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival		study period

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival		every 6 weeks
Overall Response Rate according to RECIST criteria		every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
Metastatic disease previously treated with a gemcitabine-based regimen

Exclusion Criteria:

Locally advanced disease
More than one prior chemotherapy-line for advanced pancreatic disease
Prior treatment with fluoropyrimidines for advanced pancreatic cancer
Eastern Cooperative Oncology Group (ECOG) performance status >or= 2
Poor kidney, liver or bone marrow functions
Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
Unable to swallow capsules
Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines
Concurrent participation in another clinical trial or treatment with any other anticancer therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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
Clinical Sciences & Operations	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

ID	Term
D010190	Pancreatic Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
C079198	S 1 (combination)
D005472	Fluorouracil