A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer (MONAVI-1)

This is an interventional treatment trial for Platinum-resistant or Refractory Ovarian Cancer Read More

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