Trials / Completed
CompletedNCT00796731
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly. Secondary objectives are: * to characterize the global safety profile * to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule * to assess preliminary evidence of anti-lymphoma activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR3419 | administered by intravenous infusion |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2008-11-24
- Last updated
- 2012-07-17
Locations
6 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00796731. Inclusion in this directory is not an endorsement.