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

Phase 2

• Conditions: Ovarian Cancer
• Interventions: Drug: Apatinib and Etoposide capsule; Drug: Apatinib

• Registration Number: NCT04383977
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-09
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) by investigator	up to 2 years	ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .

Secondary Outcome Measures

Name	Time	Method
AEs+SAEs	30 days after the last dose	Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
PFS by investigator	up to 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 investigator according to the RECIST criteria.
Overall Survival (OS)	up to 3 years	OS is the time interval from the date of randomization to death from any cause.
Pharmacokinetic characteristic	up to 2 years	Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma