Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer

December 3, 2020 updated by: Xin Huang, Sun Yat-sen University

A Phase II Study of Apatinib In Combination With Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer

The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients with platinum resistant or refractory ovarian cancer when combined with etoposide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor and it has been approved for the treatment of advanced gastric cancer. The preclinical studies suggest apatinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug apatinib when combined with a standard treatment, etoposide, for patients with platinum resistant or refractory ovarian cancer.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
  • Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
  • At least treated with one line of platinum-based chemotherapy
  • Female, age ≥18 years and ≤70 years, signed informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
  • Patients must have a life expectancy of at least 3 months.

  • Patients must have adequate organ function as defined by the following criteria:

    • White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L
    • Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN
    • Serum creatinine ≤ 1 x ULN

Exclusion Criteria:

  • Had prior exposure to apatinib or has known allegies to any of the excipients.
  • History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
  • Patients with QT interval prolongation
  • Serious, non-healing wound, active ulcer, bowel obstruction.
  • History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
  • Evidence of bleeding diathesis or coagulopathy
  • Inadequately controlled hypertension
  • Major surgical procedure within 28 days prior to Day 1
  • Symptomatic central nervous system (CNS) metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib + Etoposide

Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.

Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles.
Drug: Apatinib
Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.
Other Names:
  • Aitan
  • Apatinib mesylate tablets
Drug: Etoposide
Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles
Other Names:
  • VP-16

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Up to three years
Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Up to three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to three years
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Up to three years
Duration of Response
Time Frame: Up to three years
Duration of response was defined as the interval between the date of the first documented response by RECIST 1.1 to the date of first disease progression or death, whichever occurred earlier.
Up to three years
Frequency and severity of adverse effects as defined by CTCAE version 4.03
Time Frame: 30 days after last dose
Evaluation of adverse event rate according to CTCAE v4.03
30 days after last dose
Overall survival (OS)
Time Frame: Up to three years
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Up to three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xin Huang, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

September 10, 2019

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 13, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2016-020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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