Pancreatic NeoplasmsPhase 3PAPRIKANCT00417209
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
A Phase 3 study testing Larotaxel (XRP9881), 5-Fluorouracil and Capecitabine in people with Pancreatic Neoplasms, run by Sanofi at 21 sites in 21 countries.
Trial summary
The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Larotaxel (XRP9881), 5-Fluorouracil and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 21 sitesin 21 countries
- Study dates
- Dec 2006to Nov 2009
- 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
- Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
- Patient must be previously treated with a systemic gemcitabine based regimen
- Adequate bone marrow, kidney and liver functions
Who cannot join
- ECOG performance status (PS) of 2-3-4.
- Prior locoregional radiotherapy for pancreatic cancer.
- Symptomatic brain metastases or leptomeningeal disease.
- Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
- Other concurrent malignancy
- Other protocol-defined exclusion/inclusion criteria may apply
Trial locations and contacts
21 sites in 21 countries.
21 sites in 21 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford, Surrey
About this study
Official title: A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Larotaxel (XRP9881), 5-Fluorouracil, Capecitabine
- Keywords
- advanced pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Larotaxel (XRP9881)Drug
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
5-FluorouracilDrug
administered as IV infusion from Day 1 to Day 4
CapecitabineDrug
administered orally from Day 1 to Day 14 q3w
| Study group | Role | What they receive |
|---|---|---|
| Larotaxel (XRP9881) | Experimental | Not described Receives: Drug: Larotaxel (XRP9881) |
| 5-Fluorouracil or capecitabine | Active comparator | Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site. Receives: Drug: 5-Fluorouracil; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
Measured: study period
Secondary outcomes (1)
Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;
Measured: study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417209
- Sponsor's protocol ID
- EFC6596
- Other IDs
- EUDRACT: 2006-003086-14
- Acronym
- PAPRIKA
- Status last verified
- May 2016
- First submitted
- 28 Dec 2006
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
- ClinicalTrials.gov ID
- NCT00417209
- Acronym / sponsor ID
- PAPRIKA / EFC6596
- Conditions
- Pancreatic Neoplasms
- Keywords
- advanced pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Dec 2006 (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 purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Larotaxel (XRP9881) | Experimental | Drug: Larotaxel (XRP9881) |
| 5-Fluorouracil or capecitabine | Active comparator | Drug: 5-Fluorouracil, Drug: CapecitabineEach Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
- Patient must be previously treated with a systemic gemcitabine based regimen
- Adequate bone marrow, kidney and liver functions
Key exclusion criteria (6 listed)
- ECOG performance status (PS) of 2-3-4.
- Prior locoregional radiotherapy for pancreatic cancer.
- Symptomatic brain metastases or leptomeningeal disease.
- Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
- Other concurrent malignancy
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 |
|---|---|---|
| Larotaxel (XRP9881)administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w) | Drug | Larotaxel (XRP9881) |
| 5-Fluorouraciladministered as IV infusion from Day 1 to Day 4 | Drug | 5-Fluorouracil or capecitabine |
| Capecitabineadministered orally from Day 1 to Day 14 q3w | Drug | 5-Fluorouracil or capecitabine |
Primary outcome
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
Time frame: study period
1 secondary outcome
Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;
Time frame: study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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.
ICD study director
Sanofi
21 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Larotaxel (XRP9881), 5-Fluorouracil and Capecitabine in people with Pancreatic Neoplasms, run by Sanofi at 21 sites in 21 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, Brazil, Canada, Chile and 16 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (OS) defined as the time interval from the date of randomization to the date of death due to any cause (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 3 Jun 2016.