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Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Sun Yat-sen University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01287962
First received: January 31, 2011
Last updated: December 5, 2013
Last verified: January 2012
  Purpose

Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: apatinib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.


Secondary Outcome Measures:
  • Objective Response Rate(ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    ORR was the percentage of patients who got partial or complete response

  • Overall Survival(OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up

  • Toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.


Estimated Enrollment: 480
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apatinib
750 mg,po,QD; 28 days every cycle
Drug: apatinib
750 mg,po,QD; 28 days every cycle
Placebo Comparator: Placebo Drug: placebo
po,QD; 28 days every cycle

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 to 70 years of age
  2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions
  3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy
  4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
  5. Patients had to have recovered from any toxic effects of therapy
  6. Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation
  7. Adequate hematologic and biochemical values were required

Exclusion Criteria:

  1. Presence of small-cell lung cancer alone or with NSCLC
  2. Pregnant or breast-feeding women
  3. Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg,diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency
  4. Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
  5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
  6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
  7. Bone fracture or wounds that was not cured for a long time
  8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
  9. Mental diseases and psychotropic substances abuse
  10. Previous treatment with an experimental agent within 4 weeks
  11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
  12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287962

Locations
China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

No publications provided

Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01287962     History of Changes
Other Study ID Numbers: HENGRUI 20110301
Study First Received: January 31, 2011
Last Updated: December 5, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Apatinib
Non-small Cell Lung Cancer
VEGFR TKIs

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014