Clinical trial · Interventional
Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer
NCT03587129CI-TRIAL-00046454terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patient enter this study.
Summary
Brief summary (as posted)
For patients with "Platinum-resistant recurrent ovarian cancer" after second-line chemotherapy failure Using apatinib as a single drug Clinical efficacy observation Single study no control
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib
- description
- 1 times a day, atapinib, 500 mg, is taken orally
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Objective remission rate, ORR
- timeFrame
- 3 years
- description
- Complete remission (CR) + partial remission (PR)
Secondary outcomes (4)
- measure
- progression- free survival, PFS
- timeFrame
- 3 years
- description
- from entry time to disease progression or any cause of death
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, age ≥18 years, signed informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 3. Patients must have a life expectancy of at least 3 months. 4. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. Failure of at least two-line chemotherapy OR platinum resistant ovarian cancer (defined as relapsing within 6 months after a platinum based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing during a platinum based chemotherapy). 5. Criteria for recurrence or metastasis: blood CA125 is more than 2 times the upper limit of normal value, or imaging findings (CT/MRI/PET-CT) show recurrence or metastasis, or ascites cancer cells are positive. 6. Platinum refractory or resistant criteria: relapse or metastasis within 6 months end of platinum based chemotherapy. 7. The interval time to last chemotherapy was more than 4 weeks. 8. The patient received radiotherapy or surgery for more than 4 weeks, and the wound healed completely. 9. 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) (≥ 1.0 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 10. The main organs (liver, kidney and heart) function are basically normal. Exclusion Criteria: 1. Had prior exposure to apatinib or has known allegies to apatinib. 2. History of other malignant tumors (except those with cured basal cell carcinoma and cervical carcinoma in situ). 3. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1. 4. Patients with QT interval prolongation. 5. Inadequately controlled hypertension. 6. Serious, non-healing wound, active ulcer, bowel obstruction. 7. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1. 8. Evidence of bleeding diathesis or coagulopathy. 9. Patients with positive urine protein. 10. Major surgical procedure within 28 days prior to Day 1. 11. Symptomatic central nervous system (CNS) metastasis.
References
Publications (15)
- RESULTParmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Trope C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106. doi: 10.1016/s0140-6736(03)13718-x. PMID 12826431
- RESULTAlberts DS, Liu PY, Wilczynski SP, Clouser MC, Lopez AM, Michelin DP, Lanzotti VJ, Markman M; Southwest Oncology Group. Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200). Gynecol Oncol. 2008 Jan;108(1):90-4. doi: 10.1016/j.ygyno.2007.08.075. Epub 2007 Oct 18. PMID 17949799
- RESULTOronsky B, Ray CM, Spira AI, Trepel JB, Carter CA, Cottrill HM. A brief review of the management of platinum-resistant-platinum-refractory ovarian cancer. Med Oncol. 2017 Jun;34(6):103. doi: 10.1007/s12032-017-0960-z. Epub 2017 Apr 25. PMID 28444622
- RESULTPujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. PMID 24637997
- RESULTRustin G, Vergote I, Micha JP, Duska LR, Reed N, Bendell J, Spitz D, Dark G, Hoch U, Tagliaferri M, Hannah AL, Garcia AA. A multicenter, open-label, expanded phase 2 study to evaluate the safety and efficacy of etirinotecan pegol, a polymer conjugate of irinotecan, in women with recurrent platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2017 Nov;147(2):276-282. doi: 10.1016/j.ygyno.2017.08.026. Epub 2017 Sep 19.