Back to resultsApatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Apatinib
Etoposide
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- 18 Years and older
- Epithelial ovarian, fallopian tube or primary peritoneal cancer
- Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
- EOCG performance status of 0-1
Exclusion Criteria:
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- Known hypersensitivity to any of the study drugs or excipients.
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- Congenital or acquired immune deficiency (e.g. HIV infected)
Sites / Locations
- Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apatinib and Etoposide capsule
Weekly Paclitaxel
Arm Description
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
EQ-5D-5L questionnaire
EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.
FOSI-8 questionnaire
FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.
Full Information
NCT ID
NCT04000295
First Posted
June 24, 2019
Last Updated
October 7, 2019
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04000295
Brief Title
Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib and Etoposide capsule
Arm Type
Experimental
Arm Description
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
Arm Title
Weekly Paclitaxel
Arm Type
Active Comparator
Arm Description
Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Primary Outcome Measure Information:
Title
Progression free survival(PFS) by independent review committee(IRC)
Description
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
Time Frame
up to approximately 2 years
Secondary Outcome Measure Information:
Title
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Description
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time Frame
up to approximately 2 years
Title
PFS by investigator
Description
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
Time Frame
up to approximately 2 years
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
up to approximately 2 years
Title
Overall Survival (OS)
Description
OS is the time interval from the date of randomization to death from any cause.
Time Frame
up to approximately 3 years
Title
EQ-5D-5L questionnaire
Description
EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.
Time Frame
up to approximately 2 years
Title
FOSI-8 questionnaire
Description
FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.
Time Frame
up to approximately 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 Years and older
Epithelial ovarian, fallopian tube or primary peritoneal cancer
Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
EOCG performance status of 0-1
Exclusion Criteria:
Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
Known hypersensitivity to any of the study drugs or excipients.
Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
Congenital or acquired immune deficiency (e.g. HIV infected)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoyu Zhong, M.M
Phone
+86 15045090779
Email
zhongzhaoyu@hrglobe.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lanjun Zhao, Ph.D
Phone
+86 13331180196
Email
zhaolanjun@hrglobe.cn
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Huang, professor
First Name & Middle Initial & Last Name & Degree
Chunyan Lan, professor
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
Learn more about this trial
Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
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