a study of abt-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer

Conditions: Platinum-resistant or Refractory Ovarian Cancer

Summary: abt-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.


Eligibility criteria:
inclusion criteria: * - woman older than 18 years * subjects with eastern cooperative oncology group (ecog) performance status ≤ 2 * histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum * platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy or platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted refractory patients in first line) * subjects having received at least 2 prior lines of treatments including platinum regimen * subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening * there is no limitation to prior number of therapies * patients must have documented disease progression * subjects who have measurable disease according to response evaluation criteria in solid tumors (recist) v1.1 * adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:• absolute neutrophil count ≥ 1500/ mm3 * platelets ≥ 150,000 / mm3 * hemoglobin ≥ 9.0 g/dl * renal function: serum creatinine ≤1.2mg/dl or calculated creatinine clearance ≥ 60ml/min * ast/alt ≤ 3.0× the upper limit of normal (uln); \[subjects with liver metastasis may have ast, alp, and alt less then or equal to 5.0 x uln\] * bilirubin ≤ 1.25×uln * coagulation: aptt and pt not to exceed 1.2 × uln * lvef \> 50% by echocardiograms or muga * patients must give written informed consent exclusion criteria: * patient's refusal or impossibility to perform biopsy on relapsing disease * bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption * patients with platinum refractory disease in first line * received radio-immunotherapy within 6 months of 1st dose of study drug * received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed) * consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug * patient receiving treatments strong cyp3a4 inhibitors or inducers (appendix a) * positive for hiv and vhc * predisposing condition/currently exhibiting signs of bleeding * currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis * received aspirin within 7 days of start dose of study drug * active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis * active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug) * uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration * a evidence of current/active malignancies other than ovarian cancer * pregnant or lactating women