Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

NCT03587129 | Terminated Phase 2

• 1 other identifier: 201801
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer

Keywords

epithelial ovarian cancer; ovarian cancer; platinum-resistant; platinum-refractory

Outcome Measures

Primary Outcomes (1)

• Objective remission rate, ORR

  Complete remission (CR) + partial remission (PR)

  3 years

Secondary Outcomes (4)

• progression- free survival, PFS

  3 years

• grade 3-4 hematologic or non hematologic toxicity

  3 years

• Overall survival

  3 years

• disease control rate, DCR

  3 years

Study Arms (1)

apatinib

EXPERIMENTAL

1 times a day, atapinib, 500 mg, is taken orally

Drug: Apatinib

Interventions

Apatinib DRUG

An anti-tumor Targeted drug

Also known as: Apatinib mesylate

apatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, age ≥18 years, signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have a life expectancy of at least 3 months.
• 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).
• 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.
• Platinum refractory or resistant criteria: relapse or metastasis within 6 months end of platinum based chemotherapy.
• The interval time to last chemotherapy was more than 4 weeks.
• The patient received radiotherapy or surgery for more than 4 weeks, and the wound healed completely.
• 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
• The main organs (liver, kidney and heart) function are basically normal.

You may not qualify if:

• Had prior exposure to apatinib or has known allegies to apatinib.
• History of other malignant tumors (except those with cured basal cell carcinoma and cervical carcinoma in situ).
• 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.
• Inadequately controlled hypertension.
• 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.
• Patients with positive urine protein.
• Major surgical procedure within 28 days prior to Day 1.
• Symptomatic central nervous system (CNS) metastasis.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Related Publications (15)

• Parmar 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 RESULT

• Alberts 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 RESULT

• Oronsky 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 RESULT

• Pujade-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 RESULT

• Rustin 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.

  PMID: 28935273 RESULT

• Roncolato FT, Joly F, O'Connell R, Lanceley A, Hilpert F, Buizen L, Okamoto A, Aotani E, Pignata S, Donnellan P, Oza A, Avall-Lundqvist E, Berek JS, Heitz F, Feeney A, Berton-Rigaud D, Stockler MR, King M, Friedlander M; GCIG Symptom Benefit group. Reducing Uncertainty: Predictors of Stopping Chemotherapy Early and Shortened Survival Time in Platinum Resistant/Refractory Ovarian Cancer-The GCIG Symptom Benefit Study. Oncologist. 2017 Sep;22(9):1117-1124. doi: 10.1634/theoncologist.2017-0047. Epub 2017 Jun 8.

  PMID: 28596446 RESULT

• Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. doi: 10.1200/JCO.2014.56.2728. Epub 2014 Nov 3.

  PMID: 25366685 RESULT

• Colombo N, Van Gorp T, Parma G, Amant F, Gatta G, Sessa C, Vergote I. Ovarian cancer. Crit Rev Oncol Hematol. 2006 Nov;60(2):159-79. doi: 10.1016/j.critrevonc.2006.03.004. Epub 2006 Oct 2.

  PMID: 17018256 RESULT

• Kyrgiou M, Salanti G, Pavlidis N, Paraskevaidis E, Ioannidis JP. Survival benefits with diverse chemotherapy regimens for ovarian cancer: meta-analysis of multiple treatments. J Natl Cancer Inst. 2006 Nov 15;98(22):1655-63. doi: 10.1093/jnci/djj443.

  PMID: 17105988 RESULT

• Webber K, Friedlander M. Chemotherapy for epithelial ovarian, fallopian tube and primary peritoneal cancer. Best Pract Res Clin Obstet Gynaecol. 2017 May;41:126-138. doi: 10.1016/j.bpobgyn.2016.11.004. Epub 2016 Nov 23.

  PMID: 28027849 RESULT

• Davis A, Tinker AV, Friedlander M. "Platinum resistant" ovarian cancer: what is it, who to treat and how to measure benefit? Gynecol Oncol. 2014 Jun;133(3):624-31. doi: 10.1016/j.ygyno.2014.02.038. Epub 2014 Mar 4.

  PMID: 24607285 RESULT

• Naora H, Montell DJ. Ovarian cancer metastasis: integrating insights from disparate model organisms. Nat Rev Cancer. 2005 May;5(5):355-66. doi: 10.1038/nrc1611.

  PMID: 15864277 RESULT

• Mu J, Abe Y, Tsutsui T, Yamamoto N, Tai XG, Niwa O, Tsujimura T, Sato B, Terano H, Fujiwara H, Hamaoka T. Inhibition of growth and metastasis of ovarian carcinoma by administering a drug capable of interfering with vascular endothelial growth factor activity. Jpn J Cancer Res. 1996 Sep;87(9):963-71. doi: 10.1111/j.1349-7006.1996.tb02127.x.

  PMID: 8878460 RESULT

• Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

  PMID: 26884585 RESULT

• Deng L, Wang Y, Lu W, Liu Q, Wu J, Jin J. Apatinib treatment combined with chemotherapy for advanced epithelial ovarian cancer: a case report. Onco Targets Ther. 2017 Mar 13;10:1521-1525. doi: 10.2147/OTT.S126471. eCollection 2017.

  PMID: 28352185 RESULT

Related Links

• Surveillance, Epidemiology, and End Results program.

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

apatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• ZhiPing Liu, MD

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: July 10, 2018
• Primary Completion: June 14, 2020
• Study Completion: June 14, 2020
• Last Updated: August 5, 2020

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)