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

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

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).

Study Overview

• Status: Unknown
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Apatinib and Etoposide capsule; Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhaoyu Zhong, M.M; Phone Number: +86 15045090779; Email: zhongzhaoyu@hrglobe.cn
• Study Contact Backup: Name: Fenglin She, M.M; Phone Number: +86 18301190515; Email: shefenglin@hrglobe.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Protein Kinase Inhibitors; Etoposide; Apatinib
• Other Study ID Numbers: Ahead-OC-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No