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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01403636




Registration number
NCT01403636
Ethics application status
Date submitted
26/07/2011
Date registered
27/07/2011
Date last updated
17/03/2016

Titles & IDs
Public title
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
Scientific 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
Secondary ID [1] 0 0
2011-001616-57
Secondary ID [2] 0 0
ARD12130
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAR245409

Experimental: mantle cell - 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

Experimental: follicular lymphoma - 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

Experimental: CLL/SLL - 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose

Experimental: Diffuse large B cell lymphoma - 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose


Treatment: Drugs: SAR245409
Pharmaceutical form:capsule Route of administration: oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
Timepoint [1] 0 0
2 months to 2 years
Secondary outcome [1] 0 0
Progression free survival (PFS) at 6 months
Timepoint [1] 0 0
6 months to 2 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Clayton
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Hobart
Recruitment hospital [3] 0 0
Investigational Site Number 036005 - Kingswood
Recruitment hospital [4] 0 0
Investigational Site Number 036003 - Perth
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
7001 - Hobart
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
West Virginia
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
France
State/province [15] 0 0
Montpellier
Country [16] 0 0
France
State/province [16] 0 0
Pierre Benite Cedex
Country [17] 0 0
France
State/province [17] 0 0
Rennes
Country [18] 0 0
France
State/province [18] 0 0
Rouen Cedex
Country [19] 0 0
France
State/province [19] 0 0
Villejuif Cedex
Country [20] 0 0
Germany
State/province [20] 0 0
Frankfurt Am Main
Country [21] 0 0
Germany
State/province [21] 0 0
Jena
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Netherlands
State/province [23] 0 0
Amsterdam
Country [24] 0 0
Netherlands
State/province [24] 0 0
Groningen
Country [25] 0 0
Netherlands
State/province [25] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01403636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01403636