Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AMELIE: A Phase 3 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant or Refractory Ovarian Cancer
Actual Study Start Date: August 16, 2019
Estimated Primary Completion Date: January 2021
Estimated Study Completion Date: July 2022
Arm:
- Experimental: Apatinib and Etoposide capsule
- Active Comparator: Weekly Paclitaxel
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 280 |
| Actual Study start date | 16 August 2019 |
| Estimated Study Completion Date | 01 July 2022 |