Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer (NCT05494580) | Clinical Trial Compass
CompletedPhase 1/2
Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer
China29 participantsStarted 2022-09-22
Plain-language summary
A number of studies suggest that the combination of PARP inhibitors and antiangiogenic agents produce synergistic activities. Pamiparib is a small molecule inhibitor selectivity for both PARP1 and PARP2. Surufatinib is a novel small-molecule inhibitor that simultaneously targets tumor angiogenesis (via Vascular Endothelial Growth Factor Receptor \[VEGFR\]1, VEGFR 2, VEGFR3 and Fibroblast Growth Factor Receptor 1 \[FGFR1\]) and immune evasion (via Colony Stimulating Factor 1 Receptor \[CSF1R\]). In this trial, we aimed to evaluate the efficacy, safety and tolerability of pamiparib in combination with surufatinib in patients with platinum-resistant ovarian cancer who received prior PARP inhibitors.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended Phase 2 dose (RP2D) (Phase Ib)
Timeframe: first 21 days of treatment
2
The 6-month progression-free survival (PFS) rate (Phase II)
Timeframe: from the first drug administration up to two years
. Histological diagnosis of mucinous adenocarcinoma;
. Has received prior therapy with small molecule antiangiogenic receptor tyrosine kinase inhibitors (TKIs);
. Known or suspected allergy to any of study drugs;
. 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);
. 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;
. Major surgery within 28 days of starting study treatment;