A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
This study has been completed.
Sun Yat-sen University
Information provided by:
Jiangsu HengRui Medicine Co., Ltd.
First received: December 29, 2010
Last updated: February 9, 2012
Last verified: February 2012
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with advanced non-squamous and non-small cell lung cancer who failed two lines of chemotherapy.
Non-Small-Cell Lung Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase II Study of Apatinib as Third Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Primary Outcome Measures:
- Progression free survival [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall Survival safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- DCR(Disease control rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- ORR(objective response rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- QoL(quality of life) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
Apatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Apatinib 750 mg p.o. once daily
Placebo Comparator: Placebo
Placebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
placebo p.o. once daily
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- ≥ 18 and ≤ 70 years of age
- Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
- At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
- Have failed for 2 lines of chemotherapy including EGFR-TKI.
- ECOG performance scale 0 - 1.
- Life expectancy of more than 3 months.
- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
- More than 4 weeks after operation or radiotherapy
- More than 4 weeks for cytotoxic agents or tyrosine kinase inhibitors inhibitors
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
- signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
- Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
- Pregnant or breastfeeding women
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- PT, APTT, TT, Fbg abnormal, Receiving the therapy of thrombolysis or anticoagulation.
- Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
- Long-term untreated wounds or fractures.
- Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed.
- Abuse of alcohol or drugs
- Less than 4 weeks from the last clinical trial
- Treatment with VEGFR, PDGFR, sSRC-TKI before.
- History of any second malignancies within 3 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270386
|Department of Medical Oncology, Cancer Center, Sun Yet-sen University
|Guangzhou, Guangdong, China, 510060 |
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-sen University
||Li Zhang, Dr
||Sun Yat-sen University
No publications provided
||Li Zhang, Department of Medical Oncology, Cancer Center, Sun Yet Sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 29, 2010
||February 9, 2012
||China: Food and Drug Administration
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases