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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04383977
• Other study ID #: Ahead-OC-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2020
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Zhaoyu Zhong, M.M
• Phone: +86 15045090779
• Email: zhongzhaoyu[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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
• Apatinib
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Overall Survival (OS)	OS is the time interval from the date of randomization to death from any cause.	up to 3 years
Secondary	Pharmacokinetic characteristic	Evaluation of PK parameters Tmax of apatinib or etoposide in plasma	up to 2 years
Secondary	Pharmacokinetic characteristic	Evaluation of PK parameters Cmax of apatinib or etoposide in plasma	up to 2 years
Secondary	Pharmacokinetic characteristic	Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma	up to 2 years
Secondary	Pharmacokinetic characteristic	Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma	up to 2 years

External Links

•   Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.gov
•   ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies