Neoplasm malignant MedDRA version: 14.1 Level: PT Classification code 10028997 Term: Neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: SAR245408
Pharmaceutical Form: Capsule, hard
CAS Number: 934526-89-3
Current Sponsor code: SAR245408
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
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. 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, antiestrogens, or ovarian suppression Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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. Ongoing dose interruption for any reason. E 05. The subject has inadequate organ and marrow function as follows - Absolute neutrophil count (ANC): 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: 1.5 x ULN (or calculated creatinine clearance: 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 E 06. The subject has a baseline corrected QT interval (QTc) >470 ms. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Safety and tolerability as measured by the incidence and frequency of adverse events (AEs) and laboratory abnormalities;Timepoint(s) of evaluation of this end point: 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 to 6 weeks during the extension period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, France, Spain, United States
Contacts
Public ContactCSU Director
sanofi-aventis, s.a.
Outcome results
None listed