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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


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Neoplasm Malignant

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability as measured by the incidence and frequency of adverse events (AEs) and laboratory abnormalities

Outcome Description:

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.

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED12414

NCT ID:

NCT01587040

Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms

Name

Location

Investigational Site Number 840002Newark, New Jersey  07103
Investigational Site Number 840008Los Angeles, California  90048
Investigational Site Number 840005San Antonio, Texas  78229
Investigational Site Number 840004Boston, Massachusetts  02115
Investigational Site Number 840009Modesto, California  95355
Investigational Site Number 840006Augusta, Georgia  30912
Investigational Site Number 840001Detroit, Michigan  48201
Investigational Site Number 840003Dallas, Texas  75230
Investigational Site Number 840010Birmingham, Alabama  35205
Investigational Site Number 840015Columbus, Ohio  43210
Investigational Site Number 840007Nashville, Tennessee  37232