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

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Apatinib and Etoposide capsule; Drug: Apatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04383977

Ahead-OC-203

Details and patient eligibility

About

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) or apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with apatinib (375 mg qd).

Enrollment: 54 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients, ≥18 Years.
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 0-2

Exclusion criteria

1. Non-epithelial tumours
2. Ovarian tumours with low malignant potential
3. Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment
4. Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Apatinib-Etoposide capsule

Experimental group

Description:

Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity

Treatment:

Drug: Apatinib and Etoposide capsule

Apatinib

Active Comparator group

Description:

Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

Treatment:

Drug: Apatinib