Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer

Launched by SUN YAT-SEN UNIVERSITY · Aug 8, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for women with platinum-resistant ovarian cancer, which means their cancer has not improved after receiving platinum-based chemotherapy. The study is specifically looking at the combination of two drugs: pamiparib, which helps stop cancer cells from repairing themselves, and surufatinib, which targets the growth of blood vessels that feed tumors and helps the immune system fight cancer. The goal is to see if this combination is effective and safe for patients who have already received at least one treatment with a PARP inhibitor, another type of cancer drug.

To participate in this trial, women aged 18 to 75 with certain types of ovarian cancer—such as epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer—may be eligible. Participants need to have measurable cancer that has not responded to previous platinum therapy and must have a good performance status, meaning they can carry out daily activities with little or no assistance. Those who join the trial can expect to receive the study drugs and undergo regular check-ups to monitor their health and the treatment's effectiveness. It's important to note that the study has specific criteria for who can participate, so not everyone will qualify.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Informed Consent Form;
• • 2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
• • 3. 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;
• • 4. Patients must have received one prior PARP inhibitor therapy, and there must be a ≥ 6 month interval since treatment;
• • 5. Female participants age 18-75 years;
• • 6. Has measurable lesion per RECIST v1.1;
• • 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• • 8. Life expectancy ≥ 3 months;
• • 9. Patients must have normal organ and bone marrow function;
• • 10. 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).
• Exclusion Criteria:
• • 1. Histological diagnosis of mucinous adenocarcinoma;
• • 2. Has received prior therapy with small molecule antiangiogenic receptor tyrosine kinase inhibitors (TKIs);
• • 3. Known or suspected allergy to any of study drugs;
• • 4. 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);
• • 5. Has active ulcers, gastrointestinal perforation or obstruction;
• • 6. Active bleeding or pathologic condition that carries a high risk of bleeding;
• • 7. Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg) with or without treatment;
• • 8. Major surgery within 28 days of starting study treatment;
• • 9. Proteinuria ≥ (++) or 24 hours total urine protein \> 1.0 g;
• • 10. Uncontrolled pericardial or pleural or peritoneal effusions;
• • 11. 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;
• • 12. Known Human Immunodeficiency Virus (HIV) infection;
• • 13. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
• • 14. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study.