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NCT01403636 · ClinicalTrials.gov registry record · Phase 2

A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

A Phase 2 study of Lymphoma, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
167
Enrollment target
20
Study locations

NCT01403636 is a Phase 2 study of Lymphoma that has completed, run by Sanofi. The registered enrollment target is 167 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT01403636, a Phase 2 study of Lymphoma, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
167 participants
Enrollment target
20
Study locations

Study Summary

Primary Objective: \- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL) Secondary Objectives: * To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409 * To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL * To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

Conditions Studied

Lymphoma

Interventions

  • DRUG SAR245409

Study Locations (20)

Other

  • Investigational Site Number 036002 - Clayton
  • Investigational Site Number 036001 - Hobart
  • Investigational Site Number 036005 - Kingswood
  • Investigational Site Number 036003 - Perth
  • Investigational Site Number 056003 - Brussels
  • Investigational Site Number 056002 - Ghent
  • Investigational Site Number 056001 - Leuven
  • Investigational Site Number 250002 - Montpellier

Kentucky

  • Investigational Site Number 840013 - Lexington
  • Investigational Site Number 840007 - Paducah

California

  • Investigational Site Number 840012 - Los Angeles

Florida

  • Investigational Site Number 840104 - Fort Meyers

Georgia

  • Investigational Site Number 840006 - Augusta

Illinois

  • Investigational Site Number 840011 - Maywood

Kansas

  • Investigational Site Number 840010 - Kansas City

Massachusetts

  • Investigational Site Number 840004 - Boston

Trial Details

FieldValue
Enrollment Target 167 participants
Start Date 2011-10
Est. Completion 2014-09
Phase Phase 2

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01403636

The ClinicalTrials.gov registry entry for NCT01403636 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (65% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which SAR245409 is the first listed.

NCT01403636 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Kentucky, California.

Frequently Asked Questions

What is clinical trial NCT01403636 about?

NCT01403636 is a clinical study titled "A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia". Primary Objective: \- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphoc...

What is the current status of trial NCT01403636?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 167 participants. The study started on 2011-10. Estimated completion is 2014-09.

What conditions does trial NCT01403636 study?

This clinical trial studies the following conditions: Lymphoma.

What interventions are being tested in trial NCT01403636?

The interventions under investigation include: SAR245409 (DRUG).

Who is sponsoring clinical trial NCT01403636?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01403636 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.