Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

Exclusion criteria

• . Angina pectoris within 3 months
• . Acute myocardial infarction within 3 months
• . QTcF \> 470 msec on the screening ECG
• . A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndromes
• . Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
• . Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
• . Sterilization: Patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow- up hormone level assessment
• . Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient