Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT02591095
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02591095
Study Brief:
Protocol Section:
NCT02591095