Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
NCT ID: NCT00549185
Last Updated: 2012-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2007-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SAR3419
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0 to 2
Exclusion Criteria
* Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
* Previous radioimmunotherapy within 12 weeks
* Known intolerance to infused protein products or maytansinoids
* Poor kidney, liver and 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
* Pregnant or breast-feeding women
* Patient with reproductive potential without effective birth control methods
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Countries
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Other Identifiers
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TED6828
Identifier Type: -
Identifier Source: org_study_id
NCT00539682
Identifier Type: -
Identifier Source: nct_alias
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