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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03587129
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : September 4, 2018
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Apatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : July 10, 2021
Estimated Study Completion Date : July 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: apatinib
1 times a day, atapinib, 500 mg, is taken orally
Drug: Apatinib
An anti-tumor Targeted drug
Other Name: Apatinib mesylate

Primary Outcome Measures :
  1. Objective remission rate, ORR [ Time Frame: 3 years ]
    Complete remission (CR) + partial remission (PR)

Secondary Outcome Measures :
  1. progression- free survival, PFS [ Time Frame: 3 years ]
    from entry time to disease progression or any cause of death

  2. grade 3-4 hematologic or non hematologic toxicity [ Time Frame: 3 years ]
    defined by CTCAE version 4.0

  3. Overall survival [ Time Frame: 3 years ]
    from entry time to death of any cause

  4. disease control rate, DCR [ Time Frame: 3 years ]
    Complete remission (CR) + partial remission (PR) + disease stability (SD)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03587129

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Contact: ZhiPing Liu, MD +86-13936034546
Contact: Liu +86045185552350

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China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Liu    +86045185552350   
Contact: Zhao    +86045185552350   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
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Principal Investigator: ZhiPing Liu, MD First Affiliated Hospital of Harbin Medical University

Additional Information:
Publications of Results:

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Responsible Party: First Affiliated Hospital of Harbin Medical University Identifier: NCT03587129    
Other Study ID Numbers: 201801
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators have no other clinical trial about ovarian cancer

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Harbin Medical University:
epithelial ovarian cancer
ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action