NCT04921527 Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
| NCT ID | NCT04921527 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chipscreen Biosciences, Ltd. |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 454 participants |
| Start Date | 2021-12-20 |
| Primary Completion | 2024-12-31 |
Trial Parameters
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Brief Summary
This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.
Eligibility Criteria
Inclusion Criteria: * Willingness to sign a written informed consent document . * Female, age ≥18 yrs and ≤70 yrs. * Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma. * Patients with platinum refractory or platinum resistant ovarian cancer: * Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy; * Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks); * Radiological progression during the last treatment administered; * no more than 1 prior treatment regimens for recurrent disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * At least 1 lesion can be accurately measured, as defined by RECIST1.1. * Laboratory criter
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