Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01587040
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-214
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Andrew Wolanski, 617-632-6623,
Inclusion criteria :
- 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.
- 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.
- 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
- The subject discontinued the parental study due to toxicity.
- Ongoing Grade 3 or higher Adverse Event (AE).
- Ongoing Serious Adverse Event (SAE).
- Ongoing dose interruption for any reason.
- The subject has inadequate organ and marrow function as follows
- Absolute neutrophil count (ANC): <1500/mm3 (solid tumor patients) or <1000/mm3
- Platelets: <100,000/mm3 (solid tumor patients) or <30,000/mm3 (lymphoma patients)
- Hemoglobin: <9 g/dL (solid tumor patients) or <8 g/dL (lymphoma patients)
- Bilirubin: >1.5 mg/dL (>2.0 mg/dL for patients with Gilbert's syndrome)
- Serum creatinine: >1.5 times the upper limit of normal (1.5 x ULN) (or calculated
creatinine clearance: <60 mL/min) for solid tumor patients or >1.5 x ULN (or
calculated creatinine clearance: <40 mL/min) for lymphoma patients
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): >1.5 x ULN
- Fasting plasma glucose (FPG): ≥160 mg/dL
- Prothrombin time/international normalized ratio (PT/INR) and activated partial
thromboplastin time (aPTT) >1.5 × ULN
- The subject has a baseline corrected QT interval (QTc) >470 ms.
- The subject has a known allergy or hypersensitivity to components of the study
- 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.