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

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ClinicalTrials.gov Identifier: NCT04000295
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : October 8, 2019
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) 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

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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


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




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.



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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)

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): NCT04000295


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

Locations
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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.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04000295     History of Changes
Other Study ID Numbers: Ahead-OC-301
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: June 2019
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
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Etoposide phosphate
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors