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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apatinib and Etoposide capsule
Apatinib
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Apatinib-Etoposide capsule

    Apatinib

    Arm Description

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

    Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    AEs+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.
    Overall Survival (OS)
    OS is the time interval from the date of randomization to death from any cause.
    Pharmacokinetic characteristic
    Evaluation of PK parameters Tmax of apatinib or etoposide in plasma
    Pharmacokinetic characteristic
    Evaluation of PK parameters Cmax of apatinib or etoposide in plasma
    Pharmacokinetic characteristic
    Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma
    Pharmacokinetic characteristic
    Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    May 9, 2020
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04383977
    Brief Title
    Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant Ovarian Cancer
    Official Title
    A Phase 2 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant or Refractory Ovarian Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    June 2021 (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) 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).

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apatinib-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
    Apatinib
    Arm Type
    Active Comparator
    Arm Description
    Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib and Etoposide capsule
    Intervention Description
    Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib
    Intervention Description
    Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
    Primary Outcome Measure Information:
    Title
    Objective response rate (ORR) by investigator
    Description
    ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .
    Time Frame
    up to 2 years
    Secondary Outcome Measure Information:
    Title
    AEs+SAEs
    Description
    Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
    Time Frame
    30 days after the last dose
    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 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 3 years
    Title
    Pharmacokinetic characteristic
    Description
    Evaluation of PK parameters Tmax of apatinib or etoposide in plasma
    Time Frame
    up to 2 years
    Title
    Pharmacokinetic characteristic
    Description
    Evaluation of PK parameters Cmax of apatinib or etoposide in plasma
    Time Frame
    up to 2 years
    Title
    Pharmacokinetic characteristic
    Description
    Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma
    Time Frame
    up to 2 years
    Title
    Pharmacokinetic characteristic
    Description
    Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma
    Time Frame
    up to 2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients, ≥18 Years. 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 0-2 Exclusion Criteria: Non-epithelial tumours Ovarian tumours with low malignant potential Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.
    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
    Fenglin She, M.M
    Phone
    +86 18301190515
    Email
    shefenglin@hrglobe.cn

    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.
    Links:
    URL
    https://prsinfo.clinicaltrials.gov/results_definitions.html
    Description
    ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies
    URL
    https://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html
    Description
    Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.gov

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

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