LymphomaPhase 2NCT01403636
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
A Phase 2 study testing SAR245409 in people with Lymphoma, run by Sanofi at 30 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- SAR245409
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 30 sitesin 6 countries
- Study dates
- Oct 2011to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Good kidney and liver function
- Fasting glucose < 160 mg/dL
- No other malignancy
- Use of adequate birth control
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
United States12 sites
Investigational Site Number 840006
Augusta, Georgia, 30912
Investigational Site Number 840004
Boston, Massachusetts, 02115
Investigational Site Number 840014
Canton, Ohio, 44718
Investigational Site Number 840104
Fort Meyers, Florida, 33919
Investigational Site Number 840010
Kansas City, Kansas, 66160-7321
Investigational Site Number 840013
Lexington, Kentucky, 40536
Investigational Site Number 840012
Los Angeles, California, 90033
Investigational Site Number 840011
Maywood, Illinois, 60153
Investigational Site Number 840002
Morgantown, West Virginia, 26506
Investigational Site Number 840007
Paducah, Kentucky, 42002
Investigational Site Number 840001
Philadelphia, Pennsylvania, 19111
Investigational Site Number 840015
St Louis, Missouri, 63110
France5 sites
Investigational Site Number 250002
Montpellier, 34295
Investigational Site Number 250001
Pierre-Bénite, 69495
Investigational Site Number 250004
Rennes, 35033
Investigational Site Number 250005
Rouen, 76038
Investigational Site Number 250003
Villejuif, 94805
Australia4 sites
Investigational Site Number 036002
Clayton, 3168
Investigational Site Number 036001
Hobart, 7001
Investigational Site Number 036005
Kingswood, 2747
Investigational Site Number 036003
Perth, 6000
Belgium3 sites
Investigational Site Number 056003
Brussels, 1000
Investigational Site Number 056002
Ghent, 9000
Investigational Site Number 056001
Leuven, 3000
Germany3 sites
Investigational Site Number 276003
Frankfurt am Main, 60590
Investigational Site Number 276002
Jena, 07747
Investigational Site Number 276001
Ulm, 89081
Netherlands3 sites
Investigational Site Number 528001
Amsterdam, 1105 AZ
Investigational Site Number 528003
Groningen, 9713 GZ
Investigational Site Number 528002
Rotterdam, 3075 EA
About this study
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
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)
Read more
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
Read the 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.
- Conditions
- Lymphoma
- Being tested
- SAR245409
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR245409Drug
Pharmaceutical form:capsule Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| mantle cell | Experimental | 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose Receives: Drug: SAR245409 |
| follicular lymphoma | Experimental | 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose Receives: Drug: SAR245409 |
| CLL/SLL | Experimental | 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose Receives: Drug: SAR245409 |
| Diffuse large B cell lymphoma | Experimental | 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose Receives: Drug: SAR245409 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
Measured: 2 months to 2 years
Secondary outcomes (1)
Progression free survival (PFS) at 6 months
Measured: 6 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403636
- Sponsor's protocol ID
- ARD12130
- Other IDs
- 2011-001616-57, U1111-1118-6417
- Status last verified
- Feb 2016
- First submitted
- 26 Jul 2011
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29550382
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01403636
- Acronym / sponsor ID
- ARD12130
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mantle cell | Experimental | Drug: SAR24540950 mg twice daily: no eating for 2 hours prior and 1 hour after dose |
| follicular lymphoma | Experimental | Drug: SAR24540950 mg twice daily: no eating for 2 hours prior and 1 hour after dose |
| CLL/SLL | Experimental | Drug: SAR24540950 mg twice daily:no eating for 2 hours prior and 1 hour after dose |
| Diffuse large B cell lymphoma | Experimental | Drug: SAR24540950 mg twice daily:no eating for 2 hours prior and 1 hour after dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR245409Pharmaceutical form:capsule Route of administration: oral | Drug | CLL/SLL, Diffuse large B cell lymphoma, follicular lymphoma, mantle cell |
Primary outcome
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
Time frame: 2 months to 2 years
1 secondary outcome
Progression free survival (PFS) at 6 months
Time frame: 6 months to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 29550382Brown 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR245409 in people with Lymphoma, run by Sanofi at 30 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, France, Australia, Belgium, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR) (time frame: 2 months to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.