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Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Apatinib

Irinotecan

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring SCLC, apatinib, Irinotecan

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
Patients was treated by platinum chemotherapy drugs and was diagnosed to PD；
ECOG：0-2；
Anticipated survival time more than 3 months；
Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
Patients voluntarily entered the study and signed informed consent form (ICF).
The function in main organs of patients is normal.

Exclusion Criteria:

Blend cancer type with NSCLC or else；
Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms;
MRI, CT or venography confirmed that tumor invaded big vessels;
Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).；
Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy;
Urine protein≥++, or urine protein in 24 hours≥1.0g;
Received big surgery, had bone fracture or ulcer in 4 weeks;
Unhealed bone fracture or wound for long time;
Patients with active hepatitis B virus or hepatitis C virus infection；
Patients who received systemic antibiotic treatment of serious infections;
Pregnant and lactational woman or patients do not receive contraception;
Patients who are prone to bleed or use anticoagulant drugs.
Patients who have other uncured malignant tumors.
Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc；
Random 12 months before the artery/vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.；
Known history of hypersensitivity to apatinib or any of it components.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

controlled group

Arm Description

Patients use Apatinib Mesylate tablets combined with Irinotecan.

Patients use Irinotecan

Outcomes

Primary Outcome Measures

duration of treatment

time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib

Secondary Outcome Measures

progress free survival and overall survival

Secondary study endpoint

Full Information

NCT ID

NCT03651219

First Posted

August 3, 2018

Last Updated

August 27, 2018

Sponsor

Beijing Chest Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03651219

Brief Title

Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer

Official Title

Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer: A Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 8, 2018 (Anticipated)

Primary Completion Date

August 8, 2019 (Anticipated)

Study Completion Date

August 8, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Chest Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB&IV patients. It is a randomized controlled clinical trial.

Detailed Description

Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor. This research needs participants satisfied following criteria: Aged between 18 and 70； Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions； Patients who was treated by platinum chemotherapy drugs（including sensitive recurrency and resistant recurrency） ECOG：0-2； the function of primary organs is normal. Patients voluntarily entered the study and signed informed consent form (ICF). The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

SCLC, apatinib, Irinotecan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

experimental group: Irinotecan 80mg/m2 d1,d8 vi, apatinib mesylate tablets(250mg/d) po, 4-6 cycle（21d per cycle）; controlled group: Irinotecan 80mg/m2 d1,d8 vi, 4-6 cycle（21d per cycle）;

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Patients use Apatinib Mesylate tablets combined with Irinotecan.

Arm Title

controlled group

Arm Type

Active Comparator

Arm Description

Patients use Irinotecan

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)

Primary Outcome Measure Information:

Title

duration of treatment

Description

time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib

Time Frame

two years

Secondary Outcome Measure Information:

Title

progress free survival and overall survival

Description

Secondary study endpoint

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ； Patients was treated by platinum chemotherapy drugs and was diagnosed to PD； ECOG：0-2； Anticipated survival time more than 3 months； Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib； Patients voluntarily entered the study and signed informed consent form (ICF). The function in main organs of patients is normal. Exclusion Criteria: Blend cancer type with NSCLC or else； Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms; MRI, CT or venography confirmed that tumor invaded big vessels; Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).； Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)； Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy; Urine protein≥++, or urine protein in 24 hours≥1.0g; Received big surgery, had bone fracture or ulcer in 4 weeks; Unhealed bone fracture or wound for long time; Patients with active hepatitis B virus or hepatitis C virus infection； Patients who received systemic antibiotic treatment of serious infections; Pregnant and lactational woman or patients do not receive contraception; Patients who are prone to bleed or use anticoagulant drugs. Patients who have other uncured malignant tumors. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc； Random 12 months before the artery/vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.； Known history of hypersensitivity to apatinib or any of it components.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Zhang, Vice Director

Phone

010-89509281

bjchzhanghui@163.com

12. IPD Sharing Statement

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Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer

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