Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Etoposide; Etoposide phosphate; Paclitaxel

Criteria

Inclusion Criteria:

1. 18 Years and older

2. Epithelial ovarian, fallopian tube or primary peritoneal cancer

3. Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)

4. EOCG performance status of 0-1

Exclusion Criteria:

1. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)

2. Known hypersensitivity to any of the study drugs or excipients.

3. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);

4. Congenital or acquired immune deficiency (e.g. HIV infected)