Open label treatment extension study with SAR245408 or SAR245409 as a monotherapy or as a combination regime

Conditions: eoplasm malignant
MedDRA version: 17.0Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-006140-78-BE

Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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

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

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 = 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Safety will be assessed continuously.<br>Subjects will have a visit on site every week<br>(Cycle 1) or every 2 weeks (Cycle 2) during<br>the initiation period (if applicable), and every<br>4 to 6 weeks during the extension period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

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