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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383977
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Apatinib and Etoposide capsule Drug: Apatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021


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

Active Comparator: Apatinib
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
Drug: Apatinib
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity




Primary Outcome Measures :
  1. Objective response rate (ORR) by investigator [ Time Frame: up to 2 years ]
    ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .


Secondary Outcome Measures :
  1. AEs+SAEs [ Time Frame: 30 days after the last dose ]
    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 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. Overall Survival (OS) [ Time Frame: up to 3 years ]
    OS is the time interval from the date of randomization to death from any cause.

  4. Pharmacokinetic characteristic [ Time Frame: up to 2 years ]
    Evaluation of PK parameters Tmax of apatinib or etoposide in plasma

  5. Pharmacokinetic characteristic [ Time Frame: up to 2 years ]
    Evaluation of PK parameters Cmax of apatinib or etoposide in plasma

  6. Pharmacokinetic characteristic [ Time Frame: up to 2 years ]
    Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma

  7. Pharmacokinetic characteristic [ Time Frame: up to 2 years ]
    Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma



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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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383977


Contacts
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Contact: Zhaoyu Zhong, M.M +86 15045090779 zhongzhaoyu@hrglobe.cn
Contact: Fenglin She, M.M +86 18301190515 shefenglin@hrglobe.cn

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Additional Information:
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04383977    
Other Study ID Numbers: Ahead-OC-203
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Etoposide
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors