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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant or Refractory Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Apatinib and Etoposide capsule
* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib-Etoposide capsule<br>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<br>* Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity<br>|
| Active Comparator: Apatinib<br>Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity | Drug: Apatinib<br>* Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |