Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Mei Kai, Ph.D
- Phone Number: 18111277629
- Email: 250450418@qq.com
Study Locations
-
-
Sichuan
-
Chendu, Sichuan, China, 600000
- Recruiting
- Sichuan Cancer Hospital
-
Contact:
- Kai Mei, Phd
- Phone Number: 13011827280
- Email: 250450418@qq.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: experimental group
apatinib 500 mg p.o. once daily
|
Patients in experimental group will take 500mg apatinib daily orally,and patients in control group will take placebo
|
|
Placebo Comparator: control group
placebo p.o. once daily
|
Physical properties of placebos are consistent with apatinib
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: approximately 2 years
|
Time from randomization until disease progression or death
|
approximately 2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: approximately 2 years
|
Time from randomization until death from any cause of death
|
approximately 2 years
|
|
Objective response rate (ORR)
Time Frame: approximately 2 years
|
Proportion of patients with reduction in tumor burden of a predefined amount
|
approximately 2 years
|
|
disease control rate (DCR)
Time Frame: approximately 2 years
|
the total proportion of patients who demonstrate a response to treatment
|
approximately 2 years
|
|
Quality of life (QoL)
Time Frame: approximately 2 years
|
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
|
approximately 2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
Other Study ID Numbers
- Ahead-OV-201704
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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