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 range18 Years – 75 Years
SexFEMALE
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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;
✓. Life expectancy ≥ 3 months;
Exclusion criteria
✕. Histological diagnosis of mucinous adenocarcinoma;
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
. 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;