Back to resultsApatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Docetaxel
Sponsored by
About this trial
This is an interventional screening trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 and ≤ 75 years of age
- Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
- EGFR mutation testing negative of sensitive mutations
- At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
- Have failed for 1 lines of chemotherapy
- 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
- 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:
- Received more than one kind of chemotherapy regimens
- NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy
- Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- The center of the tumor invaded local large blood vessels
- Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
- 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.
- Less than 4 weeks from the last clinical trial
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
objective remission rate
disease control rate
Quality of life score
Full Information
NCT ID
NCT02780778
First Posted
May 3, 2016
Last Updated
May 19, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02780778
Brief Title
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Official Title
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line 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
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
YN968D1
Intervention Description
Targeted therapy Apatinib：500 mg，po，qd
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
chemotherapy Docetaxel：60mg/m²，vein input 1hour，every 3w
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
objective remission rate
Time Frame
1 Day
Title
disease control rate
Time Frame
1 Day
Title
Quality of life score
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 and ≤ 75 years of age
Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
EGFR mutation testing negative of sensitive mutations
At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
Have failed for 1 lines of chemotherapy
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
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:
Received more than one kind of chemotherapy regimens
NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy
Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
Any factors that influence the usage of oral administration
The center of the tumor invaded local large blood vessels
Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
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.
Less than 4 weeks from the last clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhanyu Pan, Master
Phone
86-13752570372
Email
wangcongalex@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanyu Pan, Master
Organizational Affiliation
National Clinical Research Center for Cancer of China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanyu Pan, Master
Phone
86-13752570372
Email
wangcongalex@126.com
12. IPD Sharing Statement
Learn more about this trial
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
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