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Ovarian CancerPhase 2NCT03587129

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

A Phase 2 study testing Apatinib in people with Ovarian Cancer, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
10 Jul 2018to 14 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

Other trials in China

About this study

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

Read the detailed description

The overall 5-year survival rate of ovarian cancer is 45%. The mortality rate of ovarian cancer accounts for the first in gynecologic cancer deaths. Ovarian cytoreductive surgery and postoperative platinum based chemotherapy are the standard treatment for advanced ovarian cancer. About 80% of ovarian cancer will eventually show relapse and metastasis. All patients with recurrent ovarian cancer will eventually develop into "platinum resistance". Platinum resistance was found in 1-6 months with platinum-free interval. There is no standard treatment protocol for recurrent ovarian cancer of "platinum resistant," usually with platinum-free single chemotherapy, such as: paclitaxel, docetaxel, liposomal doxorubicin, gemcitabine, topotecan and other. The response rate was 10%-30%, the median progression free survival was <4 months, and the median overall survival time was 12 months with platinum-free single-agent chemotherapy. The incidence of grade 3-4 hematologic or non-hematologic toxicity is about 40%. And chemotherapy has 14% mortality rate within 30 days of the start of single-agent chemotherapy in the literature reported. VEGF plays an important role in invasion and metastasis of ovarian cancer. VEGF directly stimulates tumor cell proliferation, growth and migration, and promotes ovarian cancer metastasis. The growth and metastasis of ovarian cancer cells are related to the quantity of VEGF. It has confirmed that inhibition of VEGF function can inhibit angiogenesis and inhibit the growth and metastasis of ovarian cancer cells in vivo experiments. The Chinese State Food and Drug Administration approved small molecular targeting drug, apatinib, for the treatment of advanced gastric cancer, for approval in December 13, 2014. The role of apatinib is the intracellular ATP binding site of VEGFR2 tyrosine receptor, which blocks the signal transduction of VEGF binding and leads to tumor angiogenesis inhibition. Apatinib can inhibit VEGFR2 effectively at a very low concentration, and a higher concentration can inhibit the platelet derived growth factor receptor (PDGFR), c-Kit and c-Src. Apatinib has only 20% grade 3-4 hematological and non hematological toxicity in the treatment of metastatic gastric cancer and gastro-esophageal junction adenocarcinoma. Deng et al reported one cases of progressive ovarian cancer. After 4-line chemotherapy resistance, a daily oral apatinib 500 mg was taken and a longer progression free survival (11.3 months) was obtained. Xie Congying et al of the First Affiliated Hospital of Wenzhou Medical University had a report in the 2017 ESMO conference. The report reviewed 15 cases of recurrent and metastatic ovarian cancer with a single drug atapatinib in the treatment of more than 2 lines of chemotherapeutic drug resistance. The median progression free survival was 5 months, the objective remission rate was 53.3% and the disease control rate was 73.3%. It is known from the above reports that apatinib has good efficacy and low toxicity in the treatment of "platinum resistant" recurrent ovarian cancer, but there is lack of prospective study.

Conditions
Ovarian Cancer
Being tested
Apatinib
Keywords
epithelial ovarian cancer, ovarian cancer, platinum-resistant, platinum-refractory
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called Apatinib mesylate

    An anti-tumor Targeted drug

Study groups in NCT03587129
Study groupRoleWhat they receive
apatinibExperimental1 times a day, atapinib, 500 mg, is taken orally
Receives: Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective remission rate, ORR

    Complete remission (CR) + partial remission (PR)

    Measured: 3 years

Secondary outcomes (4)

  1. progression- free survival, PFS

    from entry time to disease progression or any cause of death

    Measured: 3 years

  2. grade 3-4 hematologic or non hematologic toxicity

    defined by CTCAE version 4.0

    Measured: 3 years

  3. Overall survival

    from entry time to death of any cause

    Measured: 3 years

  4. disease control rate, DCR

    Complete remission (CR) + partial remission (PR) + disease stability (SD)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start10 Jul 2018
  3. Primary completion14 Jun 2020
  4. Study completion14 Jun 2020

Why it stopped: No patient enter this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587129
Sponsor's protocol ID
201801
Status last verified
Jul 2018
First submitted
3 Jul 2018
Last updated
5 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators have no other clinical trial about ovarian cancer

Publications

  • 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.

    PubMed 12826431

  • 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.

    PubMed 17949799

  • 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.

    PubMed 28444622

  • 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.

    PubMed 24637997

  • 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.

    PubMed 28935273

  • 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.

    PubMed 28596446

  • 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.

    PubMed 25366685

  • 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.

    PubMed 17018256

  • 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.

    PubMed 17105988

  • 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.

    PubMed 28027849

  • 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.

    PubMed 24607285

  • 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.

    PubMed 15864277

  • 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.

    PubMed 8878460

  • 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.

    PubMed 26884585

  • 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.

    PubMed 28352185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Ovarian Cancer, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: No patient enter this study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective remission rate, ORR (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03587129, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.

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