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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Oral
Oral
Sun Yat-sen University Cancer Cetntre
Guangzhou, China
Recommended Phase 2 dose (RP2D) (Phase Ib)
Determine the RP2D of the pamiparib and surufatinib combination
Time frame: first 21 days of treatment
The 6-month progression-free survival (PFS) rate (Phase II)
The percentage of patients alive without documented progression 6 months after treatment initiation.
Time frame: from the first drug administration up to two years
Objective response rate (ORR)
The proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame: from the first drug administration up to two years
Disease Control Rate (DCR)
Proportion of patients whose best overall response is either CR, PR, or SD.
Time frame: from the first drug administration up to two years
Duration of response (DOR)
Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first.
Time frame: from the first drug administration up to two years
Overall survival (OS)
Time from the date of first study treatment administration to the date of death due to any cause.
Time frame: from the first drug administration up to 2 years
Safety and tolerability
Incidence, nature, and severity of adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: up to 90 days after last study treatment administration
Patient Reported Outcomes (PROs)
Determination of changes in PROs with Functional Assessment of Cancer Therapy for patients with ovarian cancer (FACT-O) questionnaire
Time frame: from the first drug administration up to two years
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