Clinical trial NCT01403636: A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
timeFrame: 2 months to 2 years
Secondary outcomes:
measure: Progression free survival (PFS) at 6 months
timeFrame: 6 months to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigational Site Number 840012
state: California
city: Fort Meyers
country: United States
facility: Investigational Site Number 840104
state: Florida
city: Augusta
country: United States
facility: Investigational Site Number 840006
state: Georgia
city: Maywood
country: United States
facility: Investigational Site Number 840011
state: Illinois
city: Kansas City
country: United States
facility: Investigational Site Number 840010
state: Kansas
city: Lexington
country: United States
facility: Investigational Site Number 840013
state: Kentucky
city: Paducah
country: United States
facility: Investigational Site Number 840007
state: Kentucky
city: Boston
country: United States
facility: Investigational Site Number 840004
state: Massachusetts
city: St Louis
country: United States
facility: Investigational Site Number 840015
state: Missouri
city: Canton
country: United States
facility: Investigational Site Number 840014
state: Ohio
city: Philadelphia
country: United States
facility: Investigational Site Number 840001
state: Pennsylvania
city: Morgantown
country: United States
facility: Investigational Site Number 840002
state: West Virginia
city: Clayton
country: Australia
facility: Investigational Site Number 036002
city: Hobart
country: Australia
facility: Investigational Site Number 036001
city: Kingswood
country: Australia
facility: Investigational Site Number 036005
city: Perth
country: Australia
facility: Investigational Site Number 036003
city: Bruxelles
country: Belgium
facility: Investigational Site Number 056003
city: Gent
country: Belgium
facility: Investigational Site Number 056002
city: Leuven
country: Belgium
facility: Investigational Site Number 056001
city: Montpellier
country: France
facility: Investigational Site Number 250002
city: Pierre Benite Cedex
country: France
facility: Investigational Site Number 250001
city: Rennes
country: France
facility: Investigational Site Number 250004
city: Rouen Cedex
country: France
facility: Investigational Site Number 250005
city: Villejuif Cedex
country: France
facility: Investigational Site Number 250003
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276003
city: Jena
country: Germany
facility: Investigational Site Number 276002
city: Ulm
country: Germany
facility: Investigational Site Number 276001
city: Amsterdam
country: Netherlands
facility: Investigational Site Number 528001
city: Groningen
country: Netherlands
facility: Investigational Site Number 528003
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Brown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14.