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Ovarian CancerPhase 2NCT02867956

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

A Phase 2 study testing Apatinib and Etoposide in people with Ovarian Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Apatinib and Etoposide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
10 Aug 2016to 10 Sep 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • Inadequately controlled hypertension
  • Major surgical procedure within 28 days prior to Day 1
  • Symptomatic central nervous system (CNS) metastasis

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Apatinib, Etoposide
Keywords
Ovarian cancer, Apatinib, Etoposide, Chemotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called Apatinib mesylate tablets, Aitan

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

  • EtoposideDrug

    Also called VP-16

    Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles

Study groups in NCT02867956
Study groupRoleWhat they receive
Apatinib + EtoposideExperimentalApatinib 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.
Receives: Drug: Apatinib; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    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.

    Measured: Up to three years

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    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.

    Measured: Up to three years

  2. Duration of Response

    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.

    Measured: Up to three years

  3. Frequency and severity of adverse effects as defined by CTCAE version 4.03

    Evaluation of adverse event rate according to CTCAE v4.03

    Measured: 30 days after last dose

  4. Overall survival (OS)

    Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

    Measured: Up to three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start10 Aug 2016
  3. Primary completion31 Dec 2017
  4. Study completion10 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867956
Sponsor's protocol ID
B2016-020-01
Status last verified
Mar 2026
First submitted
3 Aug 2016
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Huang X, Xie C, Tang J, He W, Yang F, Tian W, Li J, Yang Q, Shen J, Xia L, Lan C. Adipose tissue area as a predictor for the efficacy of apatinib in platinum-resistant ovarian cancer: an exploratory imaging biomarker analysis of the AEROC trial. BMC Med. 2020 Oct 5;18(1):267. doi: 10.1186/s12916-020-01733-4.

    PubMed 33012286

  • Lan CY, Wang Y, Xiong Y, Li JD, Shen JX, Li YF, Zheng M, Zhang YN, Feng YL, Liu Q, Huang HQ, Huang X. Apatinib combined with oral etoposide in patients with platinum-resistant or platinum-refractory ovarian cancer (AEROC): a phase 2, single-arm, prospective study. Lancet Oncol. 2018 Sep;19(9):1239-1246. doi: 10.1016/S1470-2045(18)30349-8. Epub 2018 Aug 3.

    PubMed 30082170

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and Etoposide in people with Ovarian Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Up to three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867956, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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