Non-Small-Cell Lung Cancer Clinical Trial
Official title:
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
Verified date | February 2012 |
Source | Jiangsu HengRui Medicine Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | September 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - = 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Medical Oncology, Cancer Center, Sun Yet-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. | Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | 8 weeks | Yes | |
Secondary | Overall Survival safety | 8 weeks | Yes | |
Secondary | DCR(Disease control rate) | 8 weeks | Yes | |
Secondary | ORR(objective response rate) | 8 weeks | Yes | |
Secondary | QoL(quality of life) | 8 weeks | Yes | |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 8 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02495233 -
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02672358 -
Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC
|
Phase 2 | |
Recruiting |
NCT05815472 -
Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
|
N/A | |
Not yet recruiting |
NCT05900219 -
Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study
|
Phase 2 | |
Not yet recruiting |
NCT04560244 -
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment
|
Phase 2 | |
Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
Completed |
NCT01924416 -
Lung Cancer Information Study (LCIS-R01)
|
N/A | |
Completed |
NCT01136083 -
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
|
N/A | |
Completed |
NCT00831454 -
Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection
|
N/A | |
Completed |
NCT00363766 -
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00913705 -
Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer
|
Phase 3 | |
Completed |
NCT01124864 -
A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.
|
Phase 2 | |
Completed |
NCT01383135 -
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
|
Early Phase 1 | |
Completed |
NCT00049998 -
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
|
Phase 3 | |
Terminated |
NCT05061537 -
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT03320044 -
Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
|
||
Recruiting |
NCT04895930 -
Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC
|
Phase 2 | |
Recruiting |
NCT03267654 -
Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance
|
Phase 2 | |
Recruiting |
NCT04401059 -
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study
|
Phase 4 | |
Not yet recruiting |
NCT02930954 -
Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance
|
Phase 2 |