A Study to Explore Pamiparib Treatment in Epithelial Ovarian Cancer After Prior PARP Inhibitor Exposure

Exclusion Criteria

• •1. Prior treatment with Pamiparib;
• •2. Patients who are candidates for surgery after disease progression;
• •3. Patients who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anti-cancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy;
• •4. Patients who have undergone major surgery/surgical therapy for any cause ≤ 4 weeks prior to starting study drug. Patients must have adequately recovered from the treatment and have a stable clinical condition before entering the study;
• •5. Patients who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Patients must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study;
• •6. Untreated and/or active brain metastases; i. A scan to confirm the absence of brain metastases is not required ii. Patients with treated brain metastases must be off corticosteroids for ≥ 14 days and have no signs or symptoms of progressive brain metastases
• •7. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation
• •8. Patients with any of the following cardiovascular criteria:
• •i. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days prior to Day 1 ii. Evidence of symptomatic pulmonary embolismwithin 4 weeks prior to Day 1 iii. Acute myocardial infarction ≤ 6 months prior to Day 1 iv. Heart failure of New York Heart Association Classification III or IV (see Appendix 12) ≤ 6 months prior to Day 1 v. ≥ Grade 2 ventricular arrhythmia ≤ 6 months prior to Day 1 vi. Cerebrovascular accident ≤ 6 months prior to Day 1
• •9. Patients with other malignant cancer i. Except for surgically excised non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated low-stage bladder cancer, ductal carcinoma in situ treated surgically with curative intent, or a malignancy diagnosed ≥ 5 years ago with no current evidence of disease and no therapy ≥ 5 years prior to Day 1
• •10. Diagnosis of myelodysplastic syndrome (MDS);
• •11. Known human immunodeficiency virus (HIV) infection, active viral hepatitis, or active tuberculosis;
• •12. Use ≤ 10 days (or ≤ 5 half-lives, whichever is shorter), prior to Day 1, or anticipated need for food or drugs known to be strong or moderate cytochrome P450 (CYP) 3A inhibitors or strong CYP3A inducers;
• •13. Pregnancy or nursing:
• •i. Females of childbearing potential require a negative serum pregnancy test ≤ 7 days before Day 1.
• •14. Known history of intolerance to the excipients of the pamiparib capsule;
• •15. Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease-causing malabsorption syndrome.
• •i. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
• •16. Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena ≤ 6 months before Day 1;
• •17. Any illness that investigator thinks makes the patient unsuitable for entry into the study;
• •18. Unsolved acute effects of prior therapy of ≥ Grade 2 i. Except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)