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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01587040
First received: April 25, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Neoplasm Malignant
Drug: SAR245408
Drug: SAR245409
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety and tolerability as measured by the incidence and frequency of adverse events (AEs) and laboratory abnormalities [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587040

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840010 Recruiting
Birmingham, Alabama, United States, 35205
United States, California
Investigational Site Number 840008 Recruiting
Los Angeles, California, United States, 90033
Investigational Site Number 840009 Recruiting
Los Angeles, California, United States, 90024
United States, Colorado
Investigational Site Number 840022 Recruiting
Denver, Colorado, United States, 80262
United States, Florida
Investigational Site Number 840104 Recruiting
Fort Meyers, Florida, United States, 33919
United States, Georgia
Investigational Site Number 840006 Recruiting
Augusta, Georgia, United States, 30912
United States, Massachusetts
Investigational Site Number 840004 Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Investigational Site Number 840001 Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Investigational Site Number 840021 Recruiting
St Louis, Missouri, United States, 63110
United States, New Jersey
Investigational Site Number 840002 Recruiting
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Investigational Site Number 840020 Active, not recruiting
Canton, Ohio, United States, 44718
Investigational Site Number 840015 Recruiting
Columbus, Ohio, United States, 43210
United States, Tennessee
Investigational Site Number 840007 Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Investigational Site Number 840003 Recruiting
Dallas, Texas, United States, 75230
Investigational Site Number 840005 Recruiting
San Antonio, Texas, United States, 78229
United States, West Virginia
Investigational Site Number 840018 Active, not recruiting
Morgantown, West Virginia, United States, 26506
Belgium
Investigational Site Number 056001 Recruiting
Leuven, Belgium, 3000
France
Investigational Site Number 250004 Active, not recruiting
Montpellier, France, 34295
Investigational Site Number 250003 Active, not recruiting
Pierre Benite Cedex, France, 69495
Investigational Site Number 250005 Active, not recruiting
Rouen Cedex, France, 76038
Spain
Investigational Site Number 724001 Completed
Barcelona, Spain, 08035
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01587040     History of Changes
Other Study ID Numbers: TED12414, 2011-006140-78, U1111-1124-1403
Study First Received: April 25, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014