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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Aventis |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00539682 |
Purpose
Primary Objective:
1. To determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as single agent every 3 weeks in patients with relapsed or refractory B-cell NHL.
Secondary Objectives:
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: SAR3419 |
Phase I |
| MedlinePlus related topics: | Cancer Lymphoma |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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) |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
SAR3419
|
Drug: SAR3419
10 mg/m^2 IV Every 3 Weeks.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anas Younes, MD | 713-792-2860 |
| United States, New York | |||||
| Memorial Sloan-Kettering | Recruiting | ||||
| New York, New York, United States, 10065 | |||||
| United States, Ohio | |||||
| Cleveland Clinic | Recruiting | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| United States, Texas | |||||
| U.T.M.D. Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Principal Investigator: Anas Younes, MD | |||||
| M.D. Anderson Cancer Center |
| Sanofi-Aventis |
| Principal Investigator: | Anas Younes, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Anas Younes, MD/Professor ) |
| Study ID Numbers: | 2006-1092 |
| First Received: | October 2, 2007 |
| Last Updated: | April 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00539682 |
| Health Authority: | United States: Food and Drug Administration |
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