A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer) Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer) Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy
Niraparib is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment
Inclusion Criteria:
Note: Patients who have received neoadjuvant chemotherapy can also be enrolled if their tumors after chemotherapy cannot be pathologically graded.
5. FIGO staging is Stage III or IV.
6. Criteria for previous surgery (meeting any of these):
7. Criteria for previous chemotherapy:
9. ECOG physical condition score of the patient shall be 0 or 1.
10. Organ function is in good condition, including:
11. Only the female patient who has been tested with pregnancy-negative result and had made a commitment to adopt effective contraption measures or to avoid sexual behavior from the start to the completion of the study and within 3 months after the last administration of study medication is eligible to be enrolled into the study. Or female patients without childbearing potential may be enrolled in the study, defined as follows:
12. Patients must be able to take medication orally and have the ability to comply with the protocol.
13. Any previous toxic and side effect of the patient has restored to CTCAE grade ≤1 or the baseline level, except for CTCAE grade ≤2 symptomatically stable sensory neuropathy or alopecia.
Exclusion Criteria:
1. Patients diagnosed with mucinous, clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, or undifferentiated ovarian cancer.
2. Stage III patients who have undergone primary tumor reductive surgery with postoperative status of R0-complete resection (with no residual lesion).
3. Patients who have undergone tumor reductive surgery more than twice.
4. Patients who plan to or have used bevacizumab as maintenance therapy after first-line platinum-containing chemotherapy. If the patient received bevacizumab in platinum-containing chemotherapy but did not receive bevacizumab as maintenance therapy, and the last dose of bevacizumab was used ≥ 28 days before signing the master informed consent form, the patient can be enrolled.
5. Patients who are known to be allergic to active or inactive ingredients of ZL-2306 (niraparib) or other drugs with similar chemical structures to ZL-2306 (niraparib).
6. Patients who have previously been treated with PARP inhibitors (including niraparib).
7. Patients who have received other study drug treatment within 4 weeks prior to the first administration or < 5 elimination half-lives of the study drug (whichever is longer).
8. Patients with ≥ grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy for more than 4 weeks.
9. Patients with transfusion-dependent anemia or thrombocytopenia, including:
10. Patients who have undergone ascites drainage within 4 weeks prior to enrollment.
11. Brain metastases or leptomeningeal metastases that have not been treated or whose symptoms have not been controlled (e.g., new or worsening symptoms or signs, or the required dose of hormones is not yet stable). Note: It is not necessary to perform an imaging scan to confirm whether there is a brain metastasis or not; patients with spinal cord compression who have received symptomatic treatment and have evidence on clinical stable status of the disease for at least 28 days could still be considered as eligible for enrollment.
12. Patients who have received a major surgery 3 weeks before the start of the study, or is subject to any surgical effect that has not yet been recovered after surgery.
13. Patients who have received palliative radiotherapy for > 20% of bone marrow 3 weeks prior to enrollment.
14. Patients suffered from invasive cancers other than ovarian cancer within 5 years prior to enrollment (except for treated carcinoma in situ of cervix, non-melanoma and ductal carcinoma in situ).
15. Patients who have been diagnosed previously or currently with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
16. Patients who have got other severe or uncontrollable diseases, including but not limited to:
17. Patients who are pregnant or breastfeeding currently, or expect to plan for pregnancy in the course of the study treatment.
18. The corrected QT interval (QTc) is more than 470 msec; if the patient has an extended QTc interval, but investigators find such a extension is caused by a cardiac pacemaker (without any other cardiac abnormality), it shall be necessary to determine whether the patient is eligible for enrollment or not based on the discussion with the study physician from the sponsor.
Wuhan, Hubei, China