Phase I/II BNC105P combination study, evaluating recommended dose of BNC105P and objective response rate, in partially platinum sensitive ovarian cancer patients in first or second relapse

niversity of Sydney0 个研究点目标入组 134 人开始时间: 2012年5月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Phase I only
•1. Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma.
•2. Progression-free interval > 4 months (as per GCIG definition of progression) after first or second line platinum (cisplatin or carboplatin) based chemotherapy.
•3. Performance status of ECOG 0-1.
•Phase II only
•1. Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
•2. Progression-free interval between 4 to 9 months after first line chemotherapy or 4 to 12 months after second-line chemotherapy with a platinum (cisplatin or carboplatin) based regimen.
•3. Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen
•4. Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria.
•5. Subjects with clinically evident ascites and/or pleural effusions must be assessable by RECIST.
•6. If the calculated GFR is 50 - 54 ml/min an isotopic GFR may be performed. If the isotopic GFR is > 55ml/min, the patient will be eligible for the study but the calculated GFR will be used for dose calculation.
•7. Performance status of ECOG 0-2
•8. Study treatment both planned and able to start within 7 days of randomisation

•Phase II only
•1. Carcinosarcoma and mucinous carcinoma
•Phase I and II
•1. Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours)
•2. More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents).
•3. Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation
•4. Chemotherapy within 20 days prior to registration.
•5. Hormonal therapy or biologic therapy within 28 days prior to registration
•6. Concurrent treatment with any experimental drugs or other anti-cancer therapy.
•7. Concurrent treatment with clopidogrel, ticlopidine, persantin and other antiplatelet agents
•8. Radiotherapy within 21 days prior to registration, or to greater than 15% of the bone marrow.
•9. Persistent toxic effects of previous chemotherapy of greater than grade 1 severity

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