Who is sponsoring NCT04000295?

NCT04000295 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What condition does NCT04000295 study?

NCT04000295 studies Ovarian Cancer.

What drugs are being tested in NCT04000295?

Interventions: Apatinib, Etoposide, Paclitaxel.

What is the status of NCT04000295?

NCT04000295 is currently UNKNOWN.

Last reviewed 2019-10-07 · How we verify

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

NCT04000295 Phase 3 UNKNOWN

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).

Details

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	280
Start date	2019-08-16
Completion	2022-07

Conditions

Ovarian Cancer

Interventions

Apatinib
Etoposide
Paclitaxel

Primary outcomes

Progression free survival(PFS) by independent review committee(IRC) — up to approximately 2 years
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST criteria

Countries

China