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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01587040
Recruitment Status : Active, not recruiting
First Posted : April 27, 2012
Last Update Posted : March 17, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary Objective:

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

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: SAR245408 Drug: SAR245409 Phase 1 Phase 2

Detailed Description:

The duration of the study for an individual subject will include:

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

    Subjects will start 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, start with initiation period; subjects must complete all the visits in the initiation period before moving to the extension period.
    • if ≥2 cycles, start with extension period; duration of extension period is unlimited.
    • Subjects who will take a SAR245408 or SAR245409 daily dose higher than their established dose of SAR245408 or SAR245409, respectively, in the parental study will enter the study on Day 1 of the initiation period.
    • Subjects who had dose interrupted in the parental study but fulfill parental protocol criteria to restart IMP treatment will enter the treatment-extension study on Day 1 of the initiation period.
    • Subjects who fulfill the parental study criteria for IMP treatment continuation but have ongoing Grade 2 AE(s) will enter the treatment-extension study on Day 1 of the initiation period.

    Subjects may continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 or SAR245409 are available to them outside of the clinical trial

  3. Follow-up assessments: 23 to 37 days after the last dose of IMP.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2012
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: SAR245409

SAR245409 as a single agent or in a combination (the following drugs may be used in combination with SAR245409:

  • letrozole
  • temozolomide
  • rituximab
  • bendamustine and rituximab)
Drug: SAR245409
Pharmaceutical form: capsule or tablet Route of administration: oral
Experimental: SAR245408

SAR245408 as a single agent or in a combination (the following drugs may be used in combination:

  • paclitaxel and carboplatin
  • letrozole
  • trastuzumab
  • paclitaxel and trastuzumab)
Drug: SAR245408
Pharmaceutical form: capsule or tablet Route of administration: oral

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability as measured by the incidence and frequency of adverse events (AEs) and laboratory abnormalities [ Time Frame: Up to 2 years ]
    Safety will be assessed continuously. Subjects will have a visit on site every week (Cycle 1) or every 2 weeks (Cycle 2) during the initiation period (if applicable), and every 4 or 6 weeks during the extension period.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria :

I 01. Males or females enrolled in Phase 1 or Phase 2 studies of SAR245408 or SAR245409 as monotherapy or in combination with other regimens who have complete data collection for the primary endpoint(s) of the parental study or who are being treated beyond the parental study cut-off and meet all the criteria to continue to be treated per the parental protocol.

I 02. All sexually active subjects (male and female) must agree to continue to use accepted methods of barrier contraception (ie, condoms) during the course of the study and for 3 months after discontinuation of study treatment. For women of childbearing potential and for men who can father a child, a second method of contraception in addition to a barrier method is recommended. Hormonal contraception should be avoided in subjects taking SAR245408 due to possible drug-drug interaction.

I 03. Female subjects of childbearing potential must have a negative pregnancy test at baseline. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression

Exclusion criteria:

E 01. The subject discontinued the parental study due to toxicity

E 02. Ongoing Grade 3 or higher Adverse Event (AE)

E 03. Ongoing Serious Adverse Event (SAE)

E 04. Subjects with ongoing dose interruption for any reason unless the subject fulfills the criteria in the parental protocol for restarting IMP. In such case subject will start the treatment-extension study on Day 1 of the initiation period

E 05. The subject has any of the following laboratory values ≥ Common Terminology of Adverse Events (CTCAE) Grade 3

  • Absolute neutrophil count (ANC),
  • Platelet count,
  • Hemoglobin,
  • Bilirubin,
  • Serum creatinine or calculated creatinine clearance,
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST),
  • Fasting plasma glucose (FPG),
  • Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT)

E 06. The subject has a baseline corrected QT interval (QTc) >481 msec or if a subject has had a QTc interval increase of ≥ 60 msec from parental protocol baseline to an absolute value of > 470 msec

E 07. The subject has a known allergy or hypersensitivity to components of the study treatment formulation(s)

E 08. The subject is pregnant or breastfeeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587040

  Show 21 Study Locations
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01587040     History of Changes
Other Study ID Numbers: TED12414
2011-006140-78 ( EudraCT Number )
U1111-1124-1403 ( Other Identifier: UTN )
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Additional relevant MeSH terms: