Clinical trial · Interventional
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
NCT02867956CI-TRIAL-00105095completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib + Etoposide
- description
- 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.
- interventionNames
- Drug: Apatinib
- Drug: Etoposide
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Up to three years
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHuang 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 33012286
- DERIVEDLan 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 30082170