Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Primary Purpose
Angiogenesis Inhibitors,Ovarian Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apatinib
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Angiogenesis Inhibitors,Ovarian Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 18 years to 70 years;
- Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer;
- unfit for radical surgery and had received second-line chemotherapy,the disease still progressed or can not tolerate the chemotherapy;
- Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1);
- Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
- Had a life expectancy of at least 12 weeks;
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum creatine ≤ 1.5 x ULN);
- Had not gastrointestinal diseases that lead to malabsorption or impact Drug absorption;
- had good compliance;
- Signed and dated informed consent.
Exclusion Criteria:
- patients who had received anti-vascular therapy;
- Allergic to any ingredients of Apatinib;
- Participated in other drug clinical researchers within four weeks;
- Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
- Severe infection;
- Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial hypertension despite standard medical management;
- Patients who received major surgical operations within 4 weeks before screening;
- Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;
- Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;
- Have a history of psychiatric abuse and can not quit or have mental disorders.
Sites / Locations
- Sichuan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
apatinib 500 mg p.o. once daily
placebo p.o. once daily
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
Time from randomization until disease progression or death
Secondary Outcome Measures
Overall survival (OS)
Time from randomization until death from any cause of death
Objective response rate (ORR)
Proportion of patients with reduction in tumor burden of a predefined amount
disease control rate (DCR)
the total proportion of patients who demonstrate a response to treatment
Quality of life (QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Full Information
NCT ID
NCT03262545
First Posted
August 22, 2017
Last Updated
August 25, 2017
Sponsor
Sichuan Cancer Hospital and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03262545
Brief Title
Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Official Title
Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2017 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.
Detailed Description
Ovarian cancer is the third most common gynecological malignancy,just less than endometrial cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after repeated chemotherapy,recurrent and metastatic ovarian cancer has become one of the major diseases that threaten women's health. There is strongly necessary to explore effective therapeutic drugs and means to improve prognosis of these patients and improve the quality of life. The study,as a double blind clinical trial ,is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were enrolled in this study, and were randomly divided into two groups--one group of 40 patients receiving apatinib,and another of 20 patients receiving placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angiogenesis Inhibitors,Ovarian Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
apatinib 500 mg p.o. once daily
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
placebo p.o. once daily
Intervention Type
Drug
Intervention Name(s)
apatinib
Intervention Description
Patients in experimental group will take 500mg apatinib daily orally,and patients in control group will take placebo
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Physical properties of placebos are consistent with apatinib
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Time from randomization until disease progression or death
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Time from randomization until death from any cause of death
Time Frame
approximately 2 years
Title
Objective response rate (ORR)
Description
Proportion of patients with reduction in tumor burden of a predefined amount
Time Frame
approximately 2 years
Title
disease control rate (DCR)
Description
the total proportion of patients who demonstrate a response to treatment
Time Frame
approximately 2 years
Title
Quality of life (QoL)
Description
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Time Frame
approximately 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years to 70 years;
Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer;
unfit for radical surgery and had received second-line chemotherapy,the disease still progressed or can not tolerate the chemotherapy;
Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1);
Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
Had a life expectancy of at least 12 weeks;
Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum creatine ≤ 1.5 x ULN);
Had not gastrointestinal diseases that lead to malabsorption or impact Drug absorption;
had good compliance;
Signed and dated informed consent.
Exclusion Criteria:
patients who had received anti-vascular therapy;
Allergic to any ingredients of Apatinib;
Participated in other drug clinical researchers within four weeks;
Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
Severe infection;
Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial hypertension despite standard medical management;
Patients who received major surgical operations within 4 weeks before screening;
Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;
Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;
Have a history of psychiatric abuse and can not quit or have mental disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Kai, Ph.D
Phone
18111277629
Email
250450418@qq.com
Facility Information:
Facility Name
Sichuan Cancer Hospital
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
600000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Mei, Phd
Phone
13011827280
Email
250450418@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
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