Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
A Phase II Study of Apatinib In Combination With Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 ovarian-cancer
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2016
CompletedStudy Start
First participant enrolled
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2019
CompletedMarch 10, 2026
March 1, 2026
1.4 years
August 3, 2016
March 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to three years
Secondary Outcomes (4)
Progression-free survival (PFS)
Up to three years
Duration of Response
Up to three years
Frequency and severity of adverse effects as defined by CTCAE version 4.03
30 days after last dose
Overall survival (OS)
Up to three years
Study Arms (1)
Apatinib + Etoposide
EXPERIMENTALApatinib 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related Publications (2)
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.
PMID: 33012286DERIVEDLan 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.
PMID: 30082170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Huang, MD
Sun Yat-Sen University Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 16, 2016
Study Start
August 10, 2016
Primary Completion
December 31, 2017
Study Completion
September 10, 2019
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP