A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer

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