Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer

NCT03262545 | Unknown Phase 2

• 1 other identifier: Ahead-OV-201704
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Angiogenesis Inhibitors，Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from randomization until disease progression or death

  approximately 2 years

Secondary Outcomes (4)

• Overall survival (OS)

  approximately 2 years

• Objective response rate (ORR)

  approximately 2 years

• disease control rate (DCR)

  approximately 2 years

• Quality of life (QoL)

  approximately 2 years

Study Arms (2)

experimental group

EXPERIMENTAL

apatinib 500 mg p.o. once daily

Drug: apatinib

control group

PLACEBO COMPARATOR

placebo p.o. once daily

Drug: Placebos

Interventions

apatinib DRUG

Patients in experimental group will take 500mg apatinib daily orally，and patients in control group will take placebo

experimental group

Placebos DRUG

Physical properties of placebos are consistent with apatinib

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 600000, China

RECRUITING

Related Publications (1)

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

  PMID: 37185961 DERIVED

MeSH Terms

Interventions

apatinib

Central Study Contacts

Mei Kai, Ph.D

CONTACT

18111277629; 250450418@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate senior doctor

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 25, 2017
• Study Start: August 27, 2017
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CN (1)