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
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014