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Indolent Non-Hodgkin LymphomaPhase 1NCT01410513

Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia

A Phase 1 study testing SAR245409 in people with Indolent Non-Hodgkin Lymphoma and Mantle Cell Lymphoma, run by Sanofi at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab Secondary Objectives: To determine the safety and tolerability of SAR245409 in combination with rituximab or bendamustine… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAR245409
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
3 sitesUnited States
Study dates
Dec 2011to May 2014
Phase
Phase 1
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

  • A confirmed diagnosis of indolent non-Hodgkin lymphoma, mantle cell lymphoma or chronic lymphocytic leukemia
  • Evaluable disease or measurable disease
  • Transfusion independent
  • Able to take oral medication
  • Male and Female subjects > 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Women of childbearing potential using adequate contraception

Who cannot join

  • Prior therapy with a PI3K, mTOR or dual PI3K/mTOR inhibitor resulting in adverse events necessitating treatment discontinuation
  • Eligible for a hematopoietic stem cell transplant (HSCT)
  • The subject has received investigational or non-investigational cytotoxic chemotherapy (i.e., cyclophosphamide), small molecule cancer therapy (i.e., imatinib), biologic cancer therapies other than rituximab (i.e., alemtuzumab, cytokines, vaccines or other monoclonal antibodies) hormonal therapy, radio- or immuno- conjugates (e.g. ibritumomab tiuxetan, tositumomab) or immunosuppressants to treat malignancy within 4 weeks prior to Cycle 1, Day 1
  • Radiation therapy within 2 weeks prior to Cycle 1, Day 1
  • Autologous Hematopoietic Stem Cell Transplant (HSCT) within the past 16 weeks
  • Prior allogeneic HSCT
Show all 16Show fewer
  • Active central nervous system (CNS) metastases or leptomeningeal involvement
  • Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody (anti-HCV)
  • Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
  • Active peptic ulcer disease requiring treatment with proton pump inhibitors (e.g. pantoprazole) or Type 2 histamine antagonists (e.g. cimetidine)
  • Diagnosis or treatment for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell or squamous cell carcinoma of the skin, an in situ malignancy or low-risk prostate cancer after curative therapy
  • Inadequate bone marrow function
  • Abnormal liver function
  • Abnormal renal function
  • Abnormal coagulation
  • 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

3 sites in 1 country.

United States3 sites

  • Investigational Site Number 840006

    Augusta, Georgia, 30912

  • Investigational Site Number 840004

    Aurora, Colorado, 80045

  • Investigational Site Number 840002

    Charleston, South Carolina, 29406

Other trials in United States

About this study

Official title: A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Rituximab or Bendamustine Plus Rituximab in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Primary Objective:

  • To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab
Read more

Secondary Objectives:

  • To determine the safety and tolerability of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL) Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)
  • To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when used in combination in subjects with iNHL, MCL or CLL
  • To determine the pharmacodynamic (PD) effects of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL
  • To determine the antitumor activity of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL
Read the detailed description

All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as there is clinical benefit.

Combination therapy with SAR245409, bendamustine and rituximab , will be administered over a 28 day cycle for up to 6 to 8 cycles.

Subjects receiving the doublet combination , SAR245409 plus rituximab will receive weekly rituximab for 4 - 8 weeks. Monthly Rituximab may be continued beyond 8 weeks.

Being tested
SAR245409
Medical subject headings
Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

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 groups in NCT01410513
Study groupRoleWhat they receive
SAR245409 + rituximabExperimentalSubjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously
Receives: Drug: SAR245409
SAR245409 + rituximab + bendamustine (iNHL, MCL)ExperimentalSubjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously.
Receives: Drug: SAR245409
SAR245409 + rituximab+ bendamustine (CLL)ExperimentalSubjects will receive oral SAR245409 twice daily continuously and monthly bendamustine and rituximab intravenously
Receives: Drug: SAR245409

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    Measured: 4 weeks to 8 weeks

Secondary outcomes (15)

  1. Number of subjects with treatment emergent adverse events

    Measured: Time from receiving first dose of SAR245409 until 30 days after the last dose

  2. Pharmacokinetics (Cmax) of SAR245409

    Measured: up to 2 months

  3. Pharmacokinetics (tmax) of SAR245409

    Measured: up to 2 months

  4. Pharmacokinetics (AUC0-12h) of SAR245409

    Measured: up to 2 months

  5. Pharmacokinetics (Ctrough) of SAR245409

    Measured: up to 2 months

  6. Pharmacokinetics (AUC) of bendamustine

    Measured: up to 2 months

  7. Pharmacokinetics (AUClast) of bendamustine

    Measured: up to 2 months

  8. Pharmacokinetics (Ceoi) of bendamustine

    Measured: up to 2 months

  9. Pharmacokinetics (tmax) of bendamustine

    Measured: up to 2 months

  10. Pharmacokinetics (Cl) of bendamustine

    Measured: up to 2 months

  11. Pharmacokinetics (Vss) of bendamustine

    Measured: up to 2 months

  12. Pharmacokinetics (AUC0-7h) of rituximab

    Measured: up to 2 months

  13. Pharmacokinetics (Ceoi) of rituximab

    Measured: up to 2 months

  14. Pharmacokinetics (tmax) of rituximab

    Measured: up to 2 months

  15. Efficacy as determined by objective response rate (ORR)

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01410513
Sponsor's protocol ID
TCD12012
Other IDs
U1111-1119-2906
Status last verified
Sep 2014
First submitted
26 Jul 2011
Last updated
1 Apr 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR245409 in people with Indolent Non-Hodgkin Lymphoma and Mantle Cell Lymphoma, run by Sanofi at 3 sites in United States.

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 7 inclusion and 16 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) (time frame: 4 weeks to 8 weeks). 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 NCT01410513.

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 1 Apr 2016; AzTrials last refreshed its copy on 31 Oct 2026.

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