The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
Primary Purpose
Apatinib in Maintenance Treatment
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Apatinib in Maintenance Treatment
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed small-cell lung cancer and extensive stage (extrathoracic metastatic disease, malignant pleural effusion, contralateral supraclavicular adenopathy, or contralateral hilar adenopathy)
- Having a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy, or combining sequential radiotherapy
- Prior treatment without c-kit targeted drugs
- Life expectancy of more than 3 months
- Age ≥ 18 years
- Oncology Group performance status of 0 to 2
- Informed consent.
Exclusion Criteria:
- Mixed lung cancer or other types of lung cancer
- Have previously received c-kit targeted drugs
- Hemoglobin<8.0 g/dL, white blood cell <3 X 10^9/L, platelet count <75 X 10^9/L, alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Patients had recent major surgery, significant hemoptysis ( 5 ml), open wounds, or brain metastases present on required pre-enrollment brain imaging or required full-dose anticoagulation
- Uncontrol hypertension, >160/100 mmHg after treatment
- Pregnant or lactating patients
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) infection
- Patients who are suffering from serious autoimmune disease
- Patients who had active infection
- Patients who are suffering from serious organ dysfunction
- Patients who are suffering from other cancer
- Other situations that the researchers considered unsuitable for this study.
- Other concurrent uncontrolled illness
Sites / Locations
- Junling LiRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Formerly Arm Label
Arm Description
Apatinib 250mg daily
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
Number of participants with Adverse events
Drug related side effects
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03129698
Brief Title
The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
Official Title
Phase II Study of Apatinib in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Junling Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.
Detailed Description
52 patients with extensive-stage small-cell lung cancer, who had a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy will receive apatinib monotherapy as maintenance therapy after chemotherapy to evaluate the efficacy and safety of maintenance apatinib after chemotherapy for small-cell lung cancer. At the same time, we will explore the correlation between efficacy and tumor stem cell markers expression by taking peripheral blood to detect tumor stem cell markers. The primary end point is progression-free survival (PFS). The secondary end point is overall survival (OS), toxicity, and the correlation between efficacy and tumor stem cell markers expression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apatinib in Maintenance Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients with untreated extensive-stage small-cell lung cancer
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Formerly Arm Label
Arm Type
Other
Arm Description
Apatinib 250mg daily
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib 250mg daily
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with Adverse events
Description
Drug related side effects
Time Frame
6 months
Title
Overall Survival
Time Frame
1 year
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:
Histologically or cytologically confirmed small-cell lung cancer and extensive stage (extrathoracic metastatic disease, malignant pleural effusion, contralateral supraclavicular adenopathy, or contralateral hilar adenopathy)
Having a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy, or combining sequential radiotherapy
Prior treatment without c-kit targeted drugs
Life expectancy of more than 3 months
Age ≥ 18 years
Oncology Group performance status of 0 to 2
Informed consent.
Exclusion Criteria:
Mixed lung cancer or other types of lung cancer
Have previously received c-kit targeted drugs
Hemoglobin<8.0 g/dL, white blood cell <3 X 10^9/L, platelet count <75 X 10^9/L, alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Patients had recent major surgery, significant hemoptysis ( 5 ml), open wounds, or brain metastases present on required pre-enrollment brain imaging or required full-dose anticoagulation
Uncontrol hypertension, >160/100 mmHg after treatment
Pregnant or lactating patients
Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) infection
Patients who are suffering from serious autoimmune disease
Patients who had active infection
Patients who are suffering from serious organ dysfunction
Patients who are suffering from other cancer
Other situations that the researchers considered unsuitable for this study.
Other concurrent uncontrolled illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junling Li, doctor
Phone
+86 13801178891
Email
lijunling@cicams.ac.cn
Facility Information:
Facility Name
Junling Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junling Li, Doctor
Phone
+86 13801178891
Email
lijunling@cicams.ac.cn
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
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