Efficacy and Adverse Effects of Niraparib in Ovarian Cancer.
Ovarian CancerOvarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Niraparib was approved by the National Medical Products Administration on December 27, 2019. It can be used as a maintenance treatment for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. On September 10, 2020, niraparib became a poly ADP-ribose polymerase inhibitor approved in China and globally, which can be used as a single agent for the maintenance treatment of first-line and recurrent ovarian cancer regardless of the patient's biomarker status. On December 28, 2020, niraparib has been included in the new version of the medical insurance catalog. At present, most studies based on niraparib are randomized controlled trials (RCTs). RCTs often have strict inclusion and exclusion criteria and they are implemented in a highly standardized environment. Its internal validity is high, but the research results may not be able to be extrapolated to practice. This study is a prospective real-world study. In this study, based on the modified Response Evaluation Criteria in Solid Tumors v.1.1 criteria, we evaluated the use of niraparib in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in the progression-free survival, overall survival, and objective control rate, etc. The safety and tolerability of niraparib and the impact on the quality of life of patients are evaluated. 10ml blood samples of enrolled patients are collected at baseline and study endpoints respectively (only for enrolled patients who agree to blood sampling) for exploratory biological marker research and exploratory pharmacogenetic analysis. Finally, the results will as a supplement to the conclusions of randomized controlled trials to provide better guidance for patients.
A Study With Intraperitoneal Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal...
Ovarian CancerFifteen women with recurrent ovarian cancer will be treated by an intraperitoneal chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4 weeks for three courses using a three-group, dose-escalation protocol with fixed dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks. Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study hypothesis is that local and systemic toxicity will increase with increasing dosage of cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5 events in any treatment group.
Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients...
Ovarian CancerThe objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients.
TIL Therapy for Metastatic Ovarian Cancer
Metastatic Ovarian CancerAdoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 is administered to support T cell acitivation and proliferation in vivo. Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma, including Ovarian Cancer. In this study TIL therapy is administered to patients with metastatic Ovarian Cancer.
REGorafenib vsTamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological...
Ovarian CarcinomaThe objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.
A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian...
Platinum-resistant or Refractory Ovarian CancerABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)...
Ovarian CancerTo characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer
The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib)...
Ovarian CancerNiraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.
A Study of Fluzoparib(SHR-3162)in BRCA1/2-mutant Relapsed Ovarian Cancer
Ovarian CancerThis is a multicenter, open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib (SHR-3162)in BRCA1/2-mutant Relapsed Ovarian Cancer.
A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory...
Rhabdoid TumorsINI1-negative Tumors2 moreThis is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study has two parts: Dose Escalation and Dose Expansion. Dose escalation for subjects with the following relapsed/refractory malignancies: Rhabdoid tumors: Atypical teratoid rhabdoid tumor (ATRT) Malignant rhabdoid tumor (MRT) Rhabdoid tumor of kidney (RTK) Selected tumors with rhabdoid features INI1-negative tumors: Epithelioid sarcoma Epithelioid malignant peripheral nerve sheath tumor Extraskeletal myxoid chondrosarcoma Myoepithelial carcinoma Renal medullary carcinoma Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval) Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment. Dose Expansion at the MTD or the RP2D Cohort 1 - ATRT (closed to enrollment) Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment) Cohort 3 - INI-negative tumors: Epithelioid sarcoma Epithelioid malignant peripheral nerve sheath tumor Extraskeletal myxoid chondrosarcoma Myoepithelial carcinoma Renal medullary carcinoma Chordoma (poorly differentiated or de-differentiated) Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)