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Clinical Study of Apatinib in the Treatment of Advanced Ovarian Cancer After the Failure of Standard Chemotherapy

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ClinicalTrials.gov Identifier: NCT03547375
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Anhui Provincial Hospital

Brief Summary:
To Observe and Evaluate the Efficacy and Safety of Apatinib in Patients With Advanced Ovarian Cancer After the Failure of Standard Chemotherapy

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

Detailed Description:
Eligible patients will receive apatinib 500mg/d po until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Apatinib in the Treatment of Advanced Ovarian Cancer After the Failure of Standard Chemotherapy
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: treatment group
Apatinib 500mg/d po,28 days as one cycle
Drug: Apatinib
Apatinib 500mg/d po,28 days as one cycle




Primary Outcome Measures :
  1. PFS [ Time Frame: An expected average of 12 weeks ]
    The time from the beginning of treatment to observing the progression of the disease or the death of any cause



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ovarian cancer confirmed by pathology;
  2. At least one measuring lesion (RECIST 1.1) or ascites (B ultrasound);
  3. Patients with advanced ovarian cancer who failed in standard treatment. Note: Advanced ovarian cancer with recurrence of platinum-resistant drug and having no possibility of surgery
  4. Baseline blood routine and biochemical indicators meet the following criteria:

    ① ANC ≥ 1.5 × 109 / L;

    • HB ≥ 90g / L;

      • PLT ≥ 100 × 109 / L; ④ ALB≥30g / L;

        • TBIL≤1.5 times the upper limit of normal (ULN); ⑥ ALT and AST<2 × ULN; ⑦ Plasma Cr<1.5 × ULN
  5. No blood transfusion , blood products, G-CSF and other hematopoietic stimulation factors were used in 14 days ;
  6. The expected survival time is longer than 3 months;
  7. The pregnancy test (serum or urine)should be carried out for women in childbearing age before 7 days into the group and the results were negative, and willing to use appropriate methods of contraception during the test and after 8 weeks out of group
  8. The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance .

Exclusion Criteria:

  1. Allergies to apatinib and/or its excipients
  2. People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-1 above coronary heart disease, arrhythmia over class I (including QTc lengthened men > 450 ms, women > 470 ms).
  3. According to NYHA standard, Ⅲ - Ⅳ cardiac insufficiency, or LVEF < 50%;
  4. Various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.);
  5. Patients with a clear tendency of gastrointestinal bleeding, including the following situations: local active ulcer lesions, and fecal occult blood (++); Patients with black stool and hematemesis in 2 months;
  6. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency;Hereditary or acquired bleeding and thrombosis tendencies (such as hemophilia,coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
  7. Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer in 4 weeks;
  8. With abdominal fistula, gastrointestinal perforation or abdominal abscess;Active patients with HBV or HCV;
  9. Active brain metastases, meningitis, cancer patients with spinal cord compression, CT or MRI examination revealed brain or soft meningeal disease (21 days before the drug treatment; the symptoms of patients with stable brain metastases can into the group, but need to be confirmed by the cerebral MRI, CT or vein imaging evaluation no cerebral hemorrhage).
  10. CT or MRI showed that the tumor lesion was less than 5 mm away from the large vessel, or the lesion invaded local large vessels;
  11. Pregnant or lactating women;
  12. Patients with a history of psychotropic substance abuse or have mental disorders;
  13. According to the researchers' judgment, patients who have serious harm to the patient's safety or affect the patients for completing the research;
  14. Subjects considered inappropriate by the researchers.

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 ClinicalTrials.gov identifier (NCT number): NCT03547375


Contacts
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Contact: Weidong Zhao, doctor 13955105591 victorzhao@163.com

Sponsors and Collaborators
Anhui Provincial Hospital

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Responsible Party: Anhui Provincial Hospital
ClinicalTrials.gov Identifier: NCT03547375     History of Changes
Other Study ID Numbers: AHTH-102
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018

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