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Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00549185
First received: October 24, 2007
Last updated: February 13, 2012
Last verified: February 2012
History of Changes

October 24, 2007
February 13, 2012
October 2007
January 2012   (final data collection date for primary outcome measure)
Incidence of Dose Limiting Toxicity(ies) at each tested dose level [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Complete list of historical versions of study NCT00549185 on ClinicalTrials.gov Archive Site
  • Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
  • Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response
  • Incidence of Adverse Events
Not Provided
Not Provided
 
Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Non-Hodgkin
Drug: SAR3419
Intravenous infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
  • ECOG performance status 0 to 2

Exclusion Criteria:

  • Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00549185
TED6828
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP