Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. L
| Condition(s) | Efficacy and Safety |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes. To explore the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide therapy in platinum-resistance relapsed Ovarian cancer patients. |
| Who can participate | Inclusion Criteria: * 18-70years old; * High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma; * Patients received at least two lines of platinum-containing chemotherapy, with recurrence occurring within six months after the last chemotherapy dose, or were platinum-refractory patients who have undergone at least two cycles of platinum-based chemotherapy; * Measurable disease as per RECIST 1.1 * ECOG 0-2; * Life expectancy ≥12 weeks; * Confirmation of BRCA1/2 mutation status; * PARPi naive; * LVEF ≥ 50%; * Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L; * Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \ |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Xing Xie |
| Locations | Zhejiang, Hangzhou, China |
| Start date | 2020-07-01 |
| NCT ID | NCT04518501 |
| Official listing | https://clinicaltrials.gov/study/NCT04518501 |