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

Pharmaceutical Solutions

SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose

Pharmaceutical form:solution

Route of administration: Intravenous

MM-121 (SAR256212)

Pharmaceutical form:tablet

Route of administration: oral

Primary Objective:

* To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors.

Secondary Objectives:

* To characterize the global safety profile of SAR245408 in combination with SAR256212
* To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination
* To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only)
* To determine the immunogenicity of SAR256212 as administered with SAR245408

There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers

Merrimack Pharmaceuticals

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphosarcoma

Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles

Pharmaceutical form: tablet Route of administration: oral

Primary Objective:

- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.

Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.

Total duration of study participation for each patient: 58 to 118 days.

A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma

A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma

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 Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers	NCT01436565	Solid Tumor Can...	MM-121 (SAR2562... SAR245408	18 Years -	Sanofi
A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma	NCT01943838	Neoplasm Malign...	SAR245408	18 Years -	Sanofi
A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma	NCT01943838	Neoplasm Malign...	SAR245408	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 sar245408

Every month we try and update this database with for sar245408 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 sar245408

Every month we try and update this database with for sar245408 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 sar245408 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.