EUCTR2011-006140-78-BE进行中（未招募）不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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