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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib and Etoposide capsule | Experimental | Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity |
|
| Weekly Paclitaxel | Active Comparator | Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to approximately 2 years |
| PFS by investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoyu Zhong, M.M | Contact | +86 15045090779 | zhongzhaoyu@hrglobe.cn | |
| Lanjun Zhao, Ph.D | Contact | +86 13331180196 | zhaolanjun@hrglobe.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D005047 | Etoposide |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Etoposide | Drug | Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d |
|
| Paclitaxel | Drug | Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2 |
|
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
| up to approximately 2 years |
| 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. | up to approximately 2 years |
| Overall Survival (OS) | OS is the time interval from the date of randomization to death from any cause. | up to approximately 3 years |
| EQ-5D-5L questionnaire | EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer. | up to approximately 2 years |
| FOSI-8 questionnaire | FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer. | up to approximately 2 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |