A phase II, open- label, controlled, randomized, multicenter study to evaluate the efficacy and safety of pertuzumab (Omnitarg™), a recombinant humanized antibody against HER2, in combination with carboplatin-based standard chemotherapy versus carboplatin-based standard chemotherapy alone in patients with platinum-sensitive recurrent ovarian cancer

F. Hoffmann-La Roche Ltd0 个研究点目标入组 148 人开始时间: 2005年8月11日最近更新: 2012年4月24日

试验速览

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•- ECOG performance status of 0 or 1.
•- Life expectancy of = 12 weeks.
•- Histologically confirmed platinum-sensitive recurrent ovarian cancer, as defined by a progression-free interval of greater than 6 months after completion of a platinum-based regimen
•- Only one previous regimen which must be platinum-based.
•- At least one measurable lesion according to RECIST or non-measurable disease. If non-measurable disease must have an elevated CA 125 level of = 2 x ULN documented by two measurements.
•- Availability of paraffin embedded tumor tissue tumor tissue sample for biomarker assessment
•- Baseline LVEF = 50% (measured by echocardiography or in exceptional cases by MUGA scan).
•- For women of childbearing potential, a negative pregnancy test must be available and they must use an effective method of contraception.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- History of CNS metastasis or with clinical evidence of CNS metastases.
•- Prior radiotherapy.
•- Inadequate bone marrow, liver function and renal function parameters as described in protocol.
•Prior treatment with any targeted therapy.
•- Prior exposure to anthracyclines as defined in protocol.
•- History of congestive heart failure NYHA grade > 2, unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease.
•- Patient with serious uncontrolled intercurrent illness
•- Pregnant or lactating women

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