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

NCT01287962 | Unknown Phase 3 DMC

• 1 other identifier: HENGRUI 20110301
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Apatinib; Non-small Cell Lung Cancer; VEGFR TKIs

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.

  24 months

Secondary Outcomes (3)

• Objective Response Rate(ORR)

  24 months

• Overall Survival(OS)

  24 months

• Toxicity

  24 months

Study Arms (2)

Apatinib

EXPERIMENTAL

750 mg，po，QD； 28 days every cycle

Drug: apatinib

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

apatinib DRUG

750 mg，po，QD； 28 days every cycle

Apatinib

placebo DRUG

po，QD； 28 days every cycle

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Presence of small-cell lung cancer alone or with NSCLC
• Pregnant or breast-feeding women
• 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
• Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)
• Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
• ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
• Bone fracture or wounds that was not cured for a long time
• Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
• Mental diseases and psychotropic substances abuse
• Previous treatment with an experimental agent within 4 weeks
• Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
• Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun Yat-Sen University (CCSU)

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Li Zhang, MD

  Cancer Center of Sun Yat-Sen University (CCSU)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: March 1, 2014
• Last Updated: December 9, 2013

Record last verified: 2012-01

Locations

CN (1)