A Phase 2 Randomized Clinical Trial of ABT-888 in Combination with Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Subjects with Recurrent High Grade Serous Ovarian Cancer

Abbott GmbH & Co. KG0 个研究点目标入组 150 人开始时间: 2010年6月24日最近更新: 2014年8月11日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Abbott GmbH & Co. KG
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

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: Female

入选标准

•1. Subject must be at least 18 years of age.
•2. Subject must have histologically (or cytologically) confirmed recurrent high grade
•serous ovarian, fallopian tube, or primary peritoneal cancer.
•3. Subjects must have had at least 1 platinum containing chemotherapy regimen for ovarian cancer and no more than a total of 3 DNA damaging or cytotoxic regimens in the past 5 years. Less than a full dose of a DNA damaging agent, possibly due to reasons such as toxicity or documented allergic reaction will not be counted toward the limit of 3. Previous treatments with biologic agents (including catumaxomab, tigatuzuzumab, abagovomab and bevacizumab), vaccines, immunostimulants, hormonal agents and signal transduction inhibitors (e.g., pazoparib, sorafenib, sunitinib, temsirolimus) are allowed and are not counted towards the limit of 3.
•4. Subjects who are resistant to platinum-based therapy; or sensitive to, but are
•unable to tolerate platinum-based therapy (i.e., deemed toxic or have a
•documented platinum allergy). Subjects must have at least a = 3 month treatment
•free interval from the last dose of platinum based therapy. They may have
•received other therapy since their last platinum therapy prior to enrolling in this
•5. Subject must be eligible to receive PLD treatment (e.g., no allergic reaction,
•normal cardiac function).
•6. Subject has either:
•? Measurable disease, defined as at least 1 unidimensionally measurable lesion
•on a CT scan as defined by RECIST version 1.130 OR
•? Non-measurable disease with an elevation of serum CA-125 level by GCIG
•criteria (baseline sample is at least twice the upper limit of normal and within
•2 weeks prior to starting treatment).31
•7. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
•8. Subject must have adequate hematologic, renal and hepatic function per
•institutional normal range as follows:
•? Bone Marrow: Absolute neutrophil count (ANC = 1,500/mm3 (1.5 × 109/L);
•Platelets = 100,000/mm3 (100 × 109/L); Hemoglobin = 9.5 g/dL (1.4 mmol/L);
•? Renal function: Serum creatinine = 1.5 × upper limit of normal (ULN) range
•OR creatinine clearance = 50 mL/min/1.73 m2 for subjects with creatinine
•levels above institutional normal;
•? Hepatic function: AST and/or ALT = 2.5 × the ULN range. For subjects with
•liver metastases, AST and/or ALT < 5 × the ULN range; Bilirubin = 1.5 × the
•? Partial Thromboplastin Time (PTT) must be = 1.5 × the ULN range and INR
•< 1.5. Subjects on anticoagulant therapy (such as Coumadin) are allowed on
•study and will have an appropriate PTT and INR as determined by the
•Investigator.
•9. Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study
•participation and for 90 days following completion of therapy. Women of
•childbearing potential must have a negative serum pregnancy test within 21 days
•prior to initiation of treatment and a negative urine pregnancy test on Cycle 1
•Day 1 and/or post menopausal women must be amenorrheic for at least 12 months
•to be considered of non-childbearing potential.
•? Total abstinence from sexual intercourse (minimum one complete menstrual
•? Vasectomized partner;
•? Hormonal contraceptives (oral, parenteral or transdermal) for at least
•3 months prior to study drug administration;
•? Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal
•ring with spermicidal jelli

排除标准

•1. Subject has previously been treated with a PARP inhibitor except as a single dose
•from the CTEP Phase 0 (A06-161) study of ABT-888.
•2. Subjects who have a history of hypersensitive reaction to the conventional
•formulation of doxorubicin HCL, or the components of PLD.
•3. Subject has received anticancer agent(s) or an investigational agent within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
•4. Subject has undergone major surgery within the previous 28 days prior to study
•drug administration.
•5. Subject with prior radiotherapy to any portion of the abdominal cavity and pelvis,
•unless for the treatment of ovarian, primary peritoneal or fallopian tube cancer.
•Subject must have completed radiation at least 28 days prior to study drug
•administration and have measurable disease outside the radiation field or
•documented progression of lesions within a previously radiated field.
•6. Subject with a known history of brain metastases.
•7. Clinically significant and uncontrolled major medical condition(s) including but
•not limited to:
•? Active uncontrolled infection;
•? Symptomatic congestive heart failure;
•? Unstable angina pectoris or cardiac arrhythmia;
•? Psychiatric illness/social situation that would limit compliance with study
•requirements.
•? Any medical condition, which in the opinion of the Study Investigator, places
•the subject at an unacceptably high risk for toxicities.
•8. Subject is pregnant or lactating.
•9. Subject has been treated or hospitalized for bowel obstruction within 28 days prior to study drug administration.
•10. Subject who requires parenteral nutrition or tube feeding and has evidence of
•partial bowel obstruction or perforation.
•11. The subject has had another active malignancy within the past 5 years except for
•any cancer in situ considered cured or non-melanoma carcinoma of the skin.
•Questions regarding the inclusion of individual subject are to be directed to the
•Abbott Medical Monitor.

研究者

发起方

Abbott GmbH & Co. KG

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