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

Lymphoma Clinical Trial

Official title:

A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403636
• Other study ID #: ARD12130
• Secondary ID: 2011-001616-57U1
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2011
• Last updated: February 17, 2016
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Tissue from an archived or fresh tumor sample

• A peripheral blood buffy coat sample is required for CLL/SLL.

• Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma

• Patient > or = 18 years old

• Eastern Cooperative Oncology Group (ECOG) performance status < or = 2. Patients with DLBCL will have ECOG < or = 1

• Adequate white blood cells and hemoglobin

• Good kidney and liver function

• Fasting glucose < 160 mg/dL

• No other malignancy

• Use of adequate birth control

Exclusion criteria:

• Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment

• Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment

• Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.

• Radiation therapy within 2 weeks of enrollment

• Autologous stem cell transplantation within 16 weeks of enrollment

• Prior allogeneic transplantation except for patients with R/R DLBCL who meet inclusion criteria

• Central nervous system (CNS) or leptomeningeal involvement. Patients with DLBCL may have active CNS or leptomeningeal involvement.

• Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology

• Primary CNS lymphoma

• Primary mediastinal B-lymphoma

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• SAR245409
Pharmaceutical form:capsule Route of administration: oral

Locations

Country	Name	City	State
Australia	Investigational Site Number 036002	Clayton
Australia	Investigational Site Number 036001	Hobart
Australia	Investigational Site Number 036005	Kingswood
Australia	Investigational Site Number 036003	Perth
Belgium	Investigational Site Number 056003	Bruxelles
Belgium	Investigational Site Number 056002	Gent
Belgium	Investigational Site Number 056001	Leuven
France	Investigational Site Number 250002	Montpellier
France	Investigational Site Number 250001	Pierre Benite Cedex
France	Investigational Site Number 250004	Rennes
France	Investigational Site Number 250005	Rouen Cedex
France	Investigational Site Number 250003	Villejuif Cedex
Germany	Investigational Site Number 276003	Frankfurt Am Main
Germany	Investigational Site Number 276002	Jena
Germany	Investigational Site Number 276001	Ulm
Netherlands	Investigational Site Number 528001	Amsterdam
Netherlands	Investigational Site Number 528003	Groningen
Netherlands	Investigational Site Number 528002	Rotterdam
United States	Investigational Site Number 840006	Augusta	Georgia
United States	Investigational Site Number 840004	Boston	Massachusetts
United States	Investigational Site Number 840014	Canton	Ohio
United States	Investigational Site Number 840104	Fort Meyers	Florida
United States	Investigational Site Number 840010	Kansas City	Kansas
United States	Investigational Site Number 840013	Lexington	Kentucky
United States	Investigational Site Number 840012	Los Angeles	California
United States	Investigational Site Number 840011	Maywood	Illinois
United States	Investigational Site Number 840002	Morgantown	West Virginia
United States	Investigational Site Number 840007	Paducah	Kentucky
United States	Investigational Site Number 840001	Philadelphia	Pennsylvania
United States	Investigational Site Number 840015	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)		2 months to 2 years	No
Secondary	Progression free survival (PFS) at 6 months		6 months to 2 years	No