Clinical trial · Interventional
Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
NCT03262545CI-TRIAL-00029303unknownPhase 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 study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.
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 |
|---|---|---|---|
| Angiogenesis Inhibitors,Ovarian Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apatinib | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- apatinib 500 mg p.o. once daily
- interventionNames
- Drug: apatinib
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- placebo p.o. once daily
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- approximately 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years to 70 years; 2. Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer; 3. unfit for radical surgery and had received second-line chemotherapy,the disease still progressed or can not tolerate the chemotherapy; 4. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1); 5. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; 6. Had a life expectancy of at least 12 weeks; 7. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.5×the upper limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum creatine ≤ 1.5 x ULN); 8. Had not gastrointestinal diseases that lead to malabsorption or impact Drug absorption; 9. had good compliance; 10. Signed and dated informed consent. Exclusion Criteria: 1. patients who had received anti-vascular therapy; 2. Allergic to any ingredients of Apatinib; 3. Participated in other drug clinical researchers within four weeks; 4. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.) 5. Severe infection; 6. Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial hypertension despite standard medical management; 7. Patients who received major surgical operations within 4 weeks before screening; 8. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 9. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 10. Have a history of psychiatric abuse and can not quit or have mental disorders.
References
Publications (1)
- DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PMID 37185961