Trials / Unknown
UnknownNCT04000295
Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib | Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d |
| DRUG | Etoposide | Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d |
| DRUG | Paclitaxel | Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2 |
Timeline
- Start date
- 2019-08-16
- Primary completion
- 2021-01-01
- Completion
- 2022-07-01
- First posted
- 2019-06-27
- Last updated
- 2019-10-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04000295. Inclusion in this directory is not an endorsement.