Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer (NCT02195973) | Clinical Trial Compass
CompletedPhase 1
Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer
United States15 participantsStarted 2014-09
Plain-language summary
The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial effects when combined with paclitaxel in women with platinum resistant ovarian cancer. Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).
Who can participate
Age range19 Years
SexFEMALE
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Inclusion criteria
✓. Hematology: WBC ≥3.0 x 10\^9/L; ANC ≥1.5 x 10\^9/L; Platelets ≥100 x 10\^9/L
✓. Renal function: Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) or 24-hour clearance greater than or equal to 50 mL/min
✓. Hepatic function: Bilirubin ≤ 1.5 x ULN and ALT, SGOT and alkaline phosphatase ≤ 2.5 x ULN
✓. Plasma creatine phosphatase (CK) less than 1.5 x ULN
✓. Serum creatinine less than or equal to 1.5 x ULN or 24-hour clearance greater than or equal to 50 mL/min
✓. No evidence of active infection requiring antibiotic therapy
✓. Hormonal therapy being utilized, as an anti-neoplastic treatment must be discontinued at least one week prior to study entry. Hormonal replacement therapy for symptom management is allowed
✓. Any prior therapy directed at the malignancy including biologic or immunologic agents, must have be discontinued at least three weeks prior to study entry
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