Combination of pamiparib and surufatinib for treating platinum-resistant ovarian cancer
Pamiparib in Combination With Surufatinib in Patients With Platinum-resistant Ovarian Cancer Who Received Prior Poly (ADP-ribose) Polymerase (PARP) Inhibitors: a Multicenter, Single-arm, Phase Ib/II Trial
This study is testing if a new combination of two drugs, pamiparib and surufatinib, can help people with ovarian cancer that hasn't responded to other treatments feel better and improve their condition.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Surufatinib |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT05494580 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy, safety, and tolerability of pamiparib, a PARP inhibitor, in combination with surufatinib, an antiangiogenic agent, in patients with platinum-resistant ovarian cancer. The study targets patients who have previously received PARP inhibitor therapy and aims to leverage the synergistic effects of these two agents. Participants must have measurable lesions and meet specific eligibility criteria, including age and performance status. The trial is designed to assess how well this combination therapy works compared to existing treatments.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 with histologically confirmed platinum-resistant ovarian cancer who have previously received PARP inhibitors.
Not a fit: Patients who have not received prior PARP inhibitor therapy or those with non-epithelial ovarian cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited choices due to platinum resistance.
How similar studies have performed: Other studies have shown promising results with similar combinations of PARP inhibitors and antiangiogenic agents, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- Sun Yat-sen University Cancer Cetntre — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Chunyan Lan, M.D.
- Email: lanchy@sysucc.org.cn
- Phone: +862087343104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.