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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib-Etoposide capsule | Experimental | Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity |
|
| Apatinib | Active Comparator | Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib and Etoposide capsule | Drug | Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) by investigator | ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline . | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 | 30 days after the last dose |
| 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. |
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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 | |
| Fenglin She, M.M | Contact | +86 18301190515 | shefenglin@hrglobe.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37969395 | Derived | Hou Z, Lan C, Huang X, Salcedo-Hernandez RA, El-Tawab S. Efficacy, safety and pharmacokinetics of apatinib plus etoposide versus apatinib alone for platinum-resistant recurrent ovarian cancer: protocol of a multicenter, open-label, randomized phase 2 trial. Transl Cancer Res. 2023 Oct 31;12(10):2959-2967. doi: 10.21037/tcr-23-1924. Epub 2023 Oct 26. |
| Label | URL |
|---|---|
| ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies | View source |
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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 |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Apatinib | Drug | Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity |
|
| up to 2 years |
| Overall Survival (OS) | OS is the time interval from the date of randomization to death from any cause. | up to 3 years |
| Pharmacokinetic characteristic | Evaluation of PK parameters Tmax of apatinib or etoposide in plasma | up to 2 years |
| Pharmacokinetic characteristic | Evaluation of PK parameters Cmax of apatinib or etoposide in plasma | up to 2 years |
| Pharmacokinetic characteristic | Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma | up to 2 years |
| Pharmacokinetic characteristic | Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma | up to 2 years |
| Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.gov | View source |
| 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 |