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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04000295
• Other study ID #: Ahead-OC-301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 16, 2019
• Est. completion date: July 2022

Study information

• Verified date: June 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Zhaoyu Zhong, M.M
• Phone: +86 15045090779
• Email: zhongzhaoyu[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
• Etoposide
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
• Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival(PFS) by independent review committee(IRC)	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	up to approximately 2 years
Secondary	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0	up to approximately 2 years
Secondary	PFS by investigator	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	up to approximately 2 years
Secondary	Objective Response Rate (ORR)	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.	up to approximately 2 years
Secondary	Overall Survival (OS)	OS is the time interval from the date of randomization to death from any cause.	up to approximately 3 years
Secondary	EQ-5D-5L questionnaire	EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.	up to approximately 2 years
Secondary	FOSI-8 questionnaire	FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.	up to approximately 2 years