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出境医 / 临床实验 / Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer

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

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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Apatinib Drug: Etoposide Drug: Paclitaxel Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: 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
 Drug: Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d

Drug: Etoposide
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
Active Comparator: Weekly Paclitaxel
Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
 Drug: Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Outcome Measures
Primary Outcome Measures :
  1. Progression free survival(PFS) by independent review committee(IRC) [ Time Frame: 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 :
  1. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: up to approximately 2 years ]
    Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0

  2. PFS by investigator [ Time Frame: 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

  3. Objective Response Rate (ORR) [ Time Frame: 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.

  4. Overall Survival (OS) [ Time Frame: up to approximately 3 years ]
    OS is the time interval from the date of randomization to death from any cause.

  5. EQ-5D-5L questionnaire [ Time Frame: up to approximately 2 years ]
    EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.

  6. FOSI-8 questionnaire [ Time Frame: up to approximately 2 years ]
    FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zhaoyu Zhong, M.M +86 15045090779 zhongzhaoyu@hrglobe.cn
Contact: Lanjun Zhao, Ph.D +86 13331180196 zhaolanjun@hrglobe.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xin Huang, professor         
Contact: Chunyan Lan, professor         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		Progression free survival(PFS) by independent review committee(IRC) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
  • Overall Survival (OS) [ Time Frame: up to approximately 3 years ]
    OS is the time interval from the date of randomization to death from any cause.
  • EQ-5D-5L questionnaire [ Time Frame: up to approximately 2 years ]
    EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.
  • FOSI-8 questionnaire [ Time Frame: up to approximately 2 years ]
    FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Apatinib
    Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
  • Drug: Etoposide
    Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
  • Drug: Paclitaxel
    Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Study Arms  ICMJE
  • Experimental: 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
    Interventions:
    • Drug: Apatinib
    • Drug: Etoposide
  • Active Comparator: Weekly Paclitaxel
    Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
    Intervention: Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhaoyu Zhong, M.M +86 15045090779 zhongzhaoyu@hrglobe.cn
Contact: Lanjun Zhao, Ph.D +86 13331180196 zhaolanjun@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000295
Other Study ID Numbers  ICMJE Ahead-OC-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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