Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Trastuzumab

Paclitaxel

Carboplatin

Temozolomide

Letrozole

Albumin-Bound Paclitaxel

Bendamustine Hydrochloride

Rituximab

Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).

Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).

Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).

Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).

Pharmaceutical form: capsule or tablet Route of administration: oral

SAR245408

SAR245409

Clinical Sciences & Operations

Primary Objective:

The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.

The duration of the study for an individual participant included:

1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal product (IMP).
2. Study treatment period(s):

   Participants started study treatment at the beginning of the initiation or extension periods based on the length of prior therapy with SAR245408 or SAR245409
   * if \<2 cycles, started with initiation period; Participant must have had completed all the visits in the initiation period before moving to the extension period.
   * if \>=2 cycles, started with extension period; duration of extension period was unlimited.
   * Participants who took a SAR245408 or SAR245409 daily dose higher than their established dose of SAR245408 or SAR245409, respectively, in the parental study entered the study on Day 1 of the initiation period.
   * Participants who had dose interrupted in the parental study but fulfilled parental protocol criteria to restart IMP treatment entered the treatment-extension study on Day 1 of the initiation period.
   * Participants who fulfilled the parental study criteria for IMP treatment continuation but had ongoing Grade 2 adverse events (AEs) entered the treatment-extension study on Day 1 of the initiation period.

   Participants continued to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 or SAR245409 were available to them outside of the clinical trial.
3. Follow-up assessments: 23 to 37 days after the last dose of IMP.

Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE \& non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation \& AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.

Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.

Sanofi

Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.

Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).

SAR245408: Monotherapy

SAR245408: Combination Regimen

SAR245409: Monotherapy

SAR245409: Combination Regimen

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study.

Trial Transparency Team

Any TEAE

Any Grade 3-4 TEAEs

Any related TEAEs

Any Grade 3-4 related TEAE

Any Serious TEAE

Any Grade 3-4 TESAE

Any related TESAE

Any Grade 3-4 related TESAE

Any TEAE leading to death

Any TEAE leading to permanent discontinuation

Any TEAE leading to dose reduction

Any TEAE leading to dose delay or interruption

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Anemia: All grades

Anemia: Grade 1

Anemia: Grade 2

Anemia: Grade 3

Anemia: Grade 4

Neutropenia: All grades

Neutropenia: Grade 1

Neutropenia: Grade 2

Neutropenia: Grade 3

Neutropenia: Grade 4

Thrombocytopenia: All grades

Thrombocytopenia: Grade 1

Thrombocytopenia: Grade 2

Thrombocytopenia: Grade 3

Thrombocytopenia: Grade 4

Analysis was performed on safety population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters

Hyperglycemia: All Grades

Hyperglycemia: Grade 1

Hyperglycemia: Grade 2

Hyperglycemia: Grade 3

Hyperglycemia: Grade 4

ASAT Increased: All Grades

ASAT Increased: Grade 1

ASAT Increased: Grade 2

ASAT Increased: Grade 3

ASAT Increased: Grade 4

ALAT Increased: All Grades

ALAT Increased: Grade 1

ALAT Increased: Grade 2

ALAT Increased: Grade 3

ALAT Increased: Grade 4

Blood Bilirubin Increased:All Grades

Blood Bilirubin Increased:Grade 1

Blood Bilirubin Increased:Grade 2

Blood Bilirubin Increased:Grade 3

Blood Bilirubin Increased:Grade 4

Hypocalcemia: All Grades

Hypocalcemia: Grade 1

Hypocalcemia: Grade 2

Hypocalcemia: Grade 3

Hypocalcemia: Grade 4

Creatinine increased: All Grades

Creatinine increased: Grade 1

Creatinine increased: Grade 2

Creatinine increased: Grade 3

Creatinine increased: Grade 4

Analysis was performed on safety population. Here, "number analyzed"= participants with available data for specified category.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters

Overall Study

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphosarcoma

escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose

escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose

Pharmaceutical form: tablet Route of administration: oral

Primary Objective:

- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.

Secondary Objectives:

* To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
* To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
* To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
* To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire.
* To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.

The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).

A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma

A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

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

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

Pharmaceutical form:capsule Route of administration: oral

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

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.

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

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

Lymphoma, Non-Hodgkin

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Subjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously

Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously.

Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine and rituximab intravenously

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 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

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.

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen	NCT01587040	Neoplasm Malign...	SAR245408 SAR245409	-	Sanofi
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma	NCT01596270	Neoplasm Malign...	SAR245409	18 Years -	Sanofi
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma	NCT01596270	Neoplasm Malign...	SAR245409	18 Years -	Sanofi
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia	NCT01403636	Lymphoma	SAR245409	18 Years -	Sanofi
Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia	NCT01410513	Indolent Non-Ho... Mantle Cell Lym... Chronic Lymphoc...	SAR245409	18 Years -	Sanofi
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia	NCT01403636	Lymphoma	SAR245409	18 Years -	Sanofi
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen	NCT01587040	Neoplasm Malign...	SAR245408 SAR245409	-	Sanofi

Spots Global Cancer Trial Database for sar245409

Every month we try and update this database with for sar245409 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sar245409

Every month we try and update this database with for sar245409 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sar245409 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.