Platinum-sensitive recurrent ovarian cancer treated with prior PARPi
Conditions
Interventions
BRCA mutant group:Take senaparib orally
BRCA wild-type group:Take senaparib orally
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study and sign the informed consent form; 2. Age>=18 years old; 3. Pathology of platinum-sensitive recurrence confirmed non-mucinous epithelial ovarian, fallopian tube or primary peritoneal cancer; 4. Received at least one line of systemic chemotherapy but no more than 3 lines in the past (neoadjuvant chemotherapy is not counted as the number of lines); 5. Received only one PARPi treatment before (PARPi exposure time requirement: for BRCA mutated populations, the duration of PARPi treatment after first-line chemotherapy is required to = 18 months, or >=12 months after second-line or third-line chemotherapy; For BRCA wild-type populations, the duration of PARPi treatment after first-line chemotherapy is required >=12 months, or >=6 months after second- or third-line chemotherapy); 6. The last chemotherapy is platinum-containing chemotherapy, and at least 4 cycles of treatment have been completed to achieve disease remission or partial response (CR or PR); (1) CR refers to measurable and/or non-measurable lesions without RECISTv1.1 criteria for imaging assessment and within the normal range of CA125. PR refers to the fact that after chemotherapy, the imaging evaluation achieves PR according to RECIST v1.1 criteria, or the imaging evaluation has no measurable lesions and/or non-measurable lesions according to RECIST v1.1 criteria, and CA125 is higher than the normal range and must not be continuously elevated; (2) The pre-treatment CA-125 measurement must meet the following criteria: if the first measurement is less than or equal to the upper limit of normal (ULN), the patient is eligible for enrollment and does not need to undergo a second sampling, and if the first measurement is greater than ULN, a second assessment must be performed at least 7 days after the first measurement. If the second assessment is >=15% higher than the first assessment, the patient is not eligible; (3) Subjects should start receiving study drug treatment within 12 weeks after the last dose of platinum-based chemotherapy; 7. Known BRCA mutation status; 8. ECOG score: 0~1; 9. Expected survival time of more than 16 weeks; 10. The function of important organs meets the following requirements (any blood products and cell growth factors are not allowed within 28 days before enrollment): absolute neutrophil count >=1.5×10^9/L; platelet >=75×10^9/L; Hemoglobin >=10g/dL; Bilirubin <=1.5 times ULN; ALT and AST <=3 times ULN; Serum creatinine <=1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Previous (within 5 years) or at the same time with other uncured malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and breast cancer without recurrence > 3 years after completion of radical surgery; 2. New York Heart Association (NYHA) grade II or above severe congestive heart failure; History of myocardial infarction or unstable angina within 6 months prior to treatment; QTc>470ms; History of stroke or transient ischemic attack within 6 months prior to treatment; 3. Subjects who have received strong CYP3A4 inhibitors or CYP3A4 strong inducers before the first dose of study drug (elution >=5 half-lives can be enrolled from the first dose of study drug) and need to continue receiving these drugs during the study; 4. Grade >=2 persistent toxicity caused by previous anticancer therapy (except for alopecia and stable grade 2 peripheral neuropathy); 5. Current or previous myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or with MDS/AML-related features; 6. Uncontrolled symptomatic brain metastases (no imaging confirmation required). Stable dose of glucocorticoids is allowed (starting at least 4 weeks prior to treatment). Patients with spinal cord compression need to complete definitive treatment and be stable >=28 days; 7. Major surgery within 2 weeks prior to study treatment, and patients must have recovered from the effects of any major surgery; 8. Presence of serious uncontrolled medical conditions (including but not limited to): uncontrolled ventricular arrhythmias New myocardial infarction within 3 months Uncontrolled severe epilepsy Uncontrolled spinal cord compression generalized interstitial lung disease (confirmed by high-resolution CT) Mental disorders affecting informed consent; 9. Conditions affecting oral administration or gastrointestinal absorption disorders; 10. Pregnant or lactating women, subjects of childbearing age refuse to accept contraceptive measures; 11. Patients with immunodeficiency (such as HIV serology positive); 12. Active hepatitis (hepatitis B or C), active hepatitis B defined as HBV DNA >=2000 IU/ml (equivalent to 104 copies/ml); Active hepatitis C is defined as HCV RNA above the lower limit of detection; 13. Known allergy to senaparib or its excipients; 14. Received whole blood transfusion within 30 days before screening (concentrated red blood cell and platelet transfusion is allowed); 15. Other situations that the investigator considers unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to first subsequent therapy or death;Time to second subsequent therapy or death; | — |
Countries
China
Contacts
Public ContactLingya Pan
Peking Union Medical College Hospital
Outcome results
None listed