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

NCT ID: NCT04383977

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2021-06-30

Brief 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).

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib-Etoposide capsule

Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity

Group Type: EXPERIMENTAL

Apatinib and Etoposide capsule

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Apatinib

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Apatinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhaoyu Zhong, M.M

Role: CONTACT

zhongzhaoyu@hrglobe.cn

+86 15045090779

Fenglin She, M.M

Role: CONTACT

shefenglin@hrglobe.cn

+86 18301190515

References

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.

Reference Type: DERIVED

PMID: 37969395 (View on PubMed)

Related Links

https://prsinfo.clinicaltrials.gov/results_definitions.html

ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies

https://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html

Checklists, templates, and examples to help gather information needed to report results to ClinicalTrials.gov

Other Identifiers

Ahead-OC-203

Identifier Type: -

Identifier Source: org_study_id