Pancreatic NeoplasmPhase 3S-1 PancreasNCT00602745
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
A Phase 3 study testing S-1 and 5-Fluorouracil in people with Pancreatic Neoplasm and Neoplasm Metastasis, run by Sanofi at 17 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm, Neoplasm Metastasis
- What is being tested?
- S-1 and 5-Fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 17 sitesin 17 countries
- Study dates
- Feb 2008to Mar 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
- Metastatic disease previously treated with a gemcitabine-based regimen
Who cannot join
- 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
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- 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.
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen
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.
- Conditions
- Pancreatic Neoplasm, Neoplasm Metastasis
- Being tested
- S-1, 5-Fluorouracil
- Keywords
- pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
oral administration
5-FluorouracilDrug
intravenous bolus
| Study group | Role | What they receive |
|---|---|---|
| 5-Fluorouracil | Active comparator | Not described Receives: Drug: 5-Fluorouracil |
| S-1 | Experimental | Not described Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: study period
Secondary outcomes (3)
Progression Free Survival
Measured: every 6 weeks
Overall Response Rate according to RECIST criteria
Measured: every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602745
- Sponsor's protocol ID
- EFC10203
- Other IDs
- S-1 - FI
- Acronym
- S-1 Pancreas
- Status last verified
- Apr 2016
- First submitted
- 16 Jan 2008
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen
- ClinicalTrials.gov ID
- NCT00602745
- Acronym / sponsor ID
- S-1 Pancreas / EFC10203
- Conditions
- Pancreatic Neoplasm, Neoplasm Metastasis
- Keywords
- pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical
- Enrolment
- 61 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Feb 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Fluorouracil | Active comparator | Drug: 5-Fluorouracil |
| S-1 | Experimental | Drug: S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
- Metastatic disease previously treated with a gemcitabine-based regimen
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1oral administration | Drug | S-1 |
| 5-Fluorouracilintravenous bolus | Drug | 5-Fluorouracil |
Primary outcome
Overall Survival
Time frame: study period
3 secondary outcomes
Progression Free Survival
Time frame: every 6 weeks
Overall Response Rate according to RECIST criteria
Time frame: every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
Time frame: every 6 weeks
Results and safety
The study was stopped early (reason given: Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-1 and 5-Fluorouracil in people with Pancreatic Neoplasm and Neoplasm Metastasis, run by Sanofi at 17 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Austria, Brazil, Canada, Costa Rica and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.