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

Phase 3

• Conditions: Ovarian Cancer
• Interventions: Drug: Apatinib; Drug: Paclitaxel; Drug: Etoposide

• Registration Number: NCT04000295
• 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) 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Study Start: 2019-08-16
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-08
• Primary Completion: 2021-01
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 280

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib and Etoposide capsule	Apatinib	Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
Weekly Paclitaxel	Paclitaxel	Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
Apatinib and Etoposide capsule	Etoposide	Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to approximately 3 years	OS is the time interval from the date of randomization to death from any cause.
EQ-5D-5L questionnaire	up to approximately 2 years	EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	up to approximately 2 years	Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
PFS by investigator	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 investigator according to the RECIST criteria
Objective Response Rate (ORR)	up to approximately 2 years	Proportion of subjects who have a complete or partial response relative to baseline as assessed per RECIST 1.1 criteria as well as Gynecologic Cancer Intergroup (GCIG) cancer antigen (CA)-125 criteria.
FOSI-8 questionnaire	up to approximately 2 years	FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China