- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547375
Clinical Study of Apatinib in the Treatment of Advanced Ovarian Cancer After the Failure of Standard Chemotherapy
May 24, 2018 updated by: Anhui Provincial Hospital
To Observe and Evaluate the Efficacy and Safety of Apatinib in Patients With Advanced Ovarian Cancer After the Failure of Standard Chemotherapy
Study Overview
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
Study Type
Interventional
Enrollment (Anticipated)
69
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weidong Zhao, doctor
- Phone Number: 13955105591
- Email: victorzhao@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ovarian cancer confirmed by pathology;
- At least one measuring lesion (RECIST 1.1) or ascites (B ultrasound);
- 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
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
- No blood transfusion , blood products, G-CSF and other hematopoietic stimulation factors were used in 14 days ;
- The expected survival time is longer than 3 months;
- 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
- The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance .
Exclusion Criteria:
- Allergies to apatinib and/or its excipients
- 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).
- According to NYHA standard, Ⅲ - Ⅳ cardiac insufficiency, or LVEF < 50%;
- Various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.);
- 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;
- 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.);
- Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer in 4 weeks;
- With abdominal fistula, gastrointestinal perforation or abdominal abscess;Active patients with HBV or HCV;
- 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).
- 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;
- Pregnant or lactating women;
- Patients with a history of psychotropic substance abuse or have mental disorders;
- According to the researchers' judgment, patients who have serious harm to the patient's safety or affect the patients for completing the research;
- Subjects considered inappropriate by the researchers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
Apatinib 500mg/d po,28 days as one cycle
|
Apatinib 500mg/d po,28 days as one cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
An expected average of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2018
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
May 24, 2018
First Submitted That Met QC Criteria
May 24, 2018
First Posted (Actual)
June 6, 2018
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- AHTH-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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