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`Trial record 2 of 8 for: larotaxel
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`Larotaxel Compared To Continuous Administration of 5FU in Advanced Pancreatic Cancer Patients
`Previously Treated With A GemcitabineContaining Regimen (PAPRIKA)
`
`This study has been completed.
`
`Sponsor:
`Sanofi
`
`Information provided by (Responsible Party):
`Sanofi
`
`ClinicalTrials.gov Identifier:
`NCT00417209
`
`First received: December 28, 2006
`Last updated: May 3, 2016
`Last verified: May 2016
`History of Changes
`
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`
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`
`No Study Results Posted
`
`Disclaimer
`
`How to Read a Study Record
`
` Purpose
`
`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 5FU 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.
`
`Condition
`
`Pancreatic Neoplasms
`
`Intervention
`
`Drug: Larotaxel (XRP9881)
`Drug: 5Fluorouracil
`Drug: Capecitabine
`
`Phase
`
`Phase 3
`
`Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Endpoint Classification: Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Open Label
`Primary Purpose: Treatment
`
`Official Title:
`
`A Randomized, Open Label MultiCenter Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration
`of 5FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A GemcitabineContaining
`Regimen
`
`Resource links provided by NLM:
`
`MedlinePlus related topics: Cancer Pancreatic Cancer
`
`Drug Information available for: Fluorouracil Capecitabine
`
`Genetic and Rare Diseases Information Center resources: Pancreatic Cancer
`
`U.S. FDA Resources
`
`Further study details as provided by Sanofi:
`
`Primary Outcome Measures:
`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 ] [ Designated as safety issue: No ]
`
`Secondary Outcome Measures:
`
`https://clinicaltrials.gov/ct2/show/NCT00417209?term=larotaxel&rank=2
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`002006
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`AVENTIS EXHIBIT 2024
`Mylan v. Aventis, IPR2016-00712
`
`
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`6/20/2016 Larotaxel Compared To Continuous Administration of 5FU in Advanced Pancreatic Cancer Patients Previously Treated With A GemcitabineContaining …
`Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECISTdefined complete response (CR) or
`partial response (PR); clinical benefit based on the measurement of tumor related symptoms; [ Time Frame: study period ]
`[ Designated as safety issue: No ]
`
`Enrollment:
`Study Start Date:
`Study Completion Date:
`Primary Completion Date:
`
`408
`December 2006
`November 2009
`July 2009 (Final data collection date for primary outcome measure)
`
`Arms
`
`Experimental: Larotaxel (XRP9881)
`
`Active Comparator: 5Fluorouracil or capecitabine
`Each Investigator must choose either IV 5FU 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.
`
`Assigned Interventions
`
`Drug: Larotaxel (XRP9881)
`administered as a 1hour IV
`infusion on Day 1 of every 3
`weeks (q3w)
`
`Drug: 5Fluorouracil
`administered as IV infusion
`from Day 1 to Day 4
`Drug: Capecitabine
`administered orally from Day 1
`to Day 14 q3w
`
` Eligibility
`
`18 Years and older
`Ages Eligible for Study:
`Both
`Genders Eligible for Study:
`Accepts Healthy Volunteers: No
`
`Criteria
`Inclusion Criteria:
`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
`Exclusion Criteria:
`ECOG performance status (PS) of 234.
`Prior locoregional radiotherapy for pancreatic cancer.
`Symptomatic brain metastases or leptomeningeal disease.
`Any serious intercurrent infections, uncontrolled cardiac or gastrointestinal diseases.
`Other concurrent malignancy
`Other protocoldefined exclusion/inclusion criteria may apply
`
` Contacts and Locations
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
`study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
`information, see Learn About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00417209
`
` Show 21 Study Locations
`
`Sponsors and Collaborators
`Sanofi
`
`Investigators
`Study Director:
`
`ICD Sanofi
`
` More Information
`
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`6/20/2016 Larotaxel Compared To Continuous Administration of 5FU in Advanced Pancreatic Cancer Patients Previously Treated With A GemcitabineContaining …
`
`Sanofi
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT00417209 History of Changes
`Other Study ID Numbers:
`EFC6596 EUDRACT: 200600308614
`Study First Received:
`December 28, 2006
`Last Updated:
`May 3, 2016
`Health Authority:
`United States: Food and Drug Administration
`United Kingdom: Medicines and Healthcare Products Regulatory Agency
`
`Keywords provided by Sanofi:
`advanced pancreatic cancer
`
`Additional relevant MeSH terms:
`Pancreatic Neoplasms
`Digestive System Diseases
`Digestive System Neoplasms
`Endocrine Gland Neoplasms
`Endocrine System Diseases
`Neoplasms
`Neoplasms by Site
`Pancreatic Diseases
`Capecitabine
`
`ClinicalTrials.gov processed this record on June 19, 2016
`
`Fluorouracil
`Antimetabolites
`Antimetabolites, Antineoplastic
`Antineoplastic Agents
`Immunologic Factors
`Immunosuppressive Agents
`Molecular Mechanisms of Pharmacological Action
`Physiological Effects of Drugs
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