Back to resultsA Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Primary Purpose
Non-Small-Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apatinib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring NSCLC, apatinib, phase II, lung, cancer
Eligibility Criteria
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.
Sites / Locations
- Department of Medical Oncology, Cancer Center, Sun Yet-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Apatinib
Placebo
Arm Description
Apatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Overall Survival safety
DCR(Disease control rate)
ORR(objective response rate)
QoL(quality of life)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT01270386
First Posted
December 29, 2010
Last Updated
February 9, 2012
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01270386
Brief Title
A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer
Keywords
NSCLC, apatinib, phase II, lung, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apatinib
Arm Type
Experimental
Arm Description
Apatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
apatinib
Intervention Description
Apatinib 750 mg p.o. once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo p.o. once daily
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall Survival safety
Time Frame
8 weeks
Title
DCR(Disease control rate)
Time Frame
8 weeks
Title
ORR(objective response rate)
Time Frame
8 weeks
Title
QoL(quality of life)
Time Frame
8 weeks
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, Dr
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
We'll reach out to this number within 24 hrs