Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer

Korábbi kezelés

• Has received prior therapy with small molecule antiangiogenic receptor tyrosine kinase inhibitors (TKIs);
• Major surgery within 28 days of starting study treatment;

Más betegség

• Known or suspected allergy to any of study drugs;
• Has active ulcers, gastrointestinal perforation or obstruction;
• Active bleeding or pathologic condition that carries a high risk of bleeding;
• Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg) with or without treatment;
• Has a diagnosed and/or treated additional malignancy within the last 5 years. Exceptions include in situ cervical cancer, non-melanoma skin cancer, or superficial bladder tumors that has undergone potentially curative therapy;
• Known Human Immunodeficiency Virus (HIV) infection;
• Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study.

Laborértékek

• Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York heart association \[NYHA\] class \> 2, unstable angina, myocardial infarction, cardiac arrhythmia associated with hemodynamic instability (including corrected QT (QTc) interval ≥ 450 ms in men, ≥ 470 ms in female);

Egyéb

• Histological diagnosis of mucinous adenocarcinoma;
• Proteinuria ≥ (++) or 24 hours total urine protein \> 1.0 g;
• Uncontrolled pericardial or pleural or peritoneal effusions;
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis;

• Signed Informed Consent Form;
• Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
• Platinum-resistant disease, defined as progression within 6 months from completion of most recent platinum-containing therapy. Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance;
• Patients must have received one prior PARP inhibitor therapy, and there must be a ≥ 6 month interval since treatment;
• Female participants age 18-75 years;
• Has measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy ≥ 3 months;
• Patients must have normal organ and bone marrow function;
• Women of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices \[IUDs\]) throughout the period of taking study treatment and for at least 6 months after the last dose of study drug(s).