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

Status: Recruiting
Phase:
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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

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 Exclusion criteria: - 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 (lymphoma patients) - 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 treatment formulation(s). - 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.
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