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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03651219
• Other study ID #: 20171301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 8, 2018
• Est. completion date: August 8, 2020

Study information

• Verified date: August 2018
• Source: Beijing Chest Hospital
• Contact: Hui Zhang, Vice Director
• Phone: 010-89509281
• Email: bjchzhanghui[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Aged between 18 and 70；

2. Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions；

3. Patients who was treated by platinum chemotherapy drugs（including sensitive recurrency and resistant recurrency）

4. ECOG：0-2；

5. the function of primary organs is normal.

6. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 8, 2020
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ;

2. Patients was treated by platinum chemotherapy drugs and was diagnosed to PD;

3. ECOG:0-2;

4. Anticipated survival time more than 3 months;

5. 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;

6. Patients voluntarily entered the study and signed informed consent form (ICF).

7. The function in main organs of patients is normal.

Exclusion Criteria:

1. Blend cancer type with NSCLC or else;

2. Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms;

3. MRI, CT or venography confirmed that tumor invaded big vessels;

4. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).;

5. Patients with with grade ? myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms);

6. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy;

7. Urine protein=++, or urine protein in 24 hours=1.0g;

8. Received big surgery, had bone fracture or ulcer in 4 weeks;

9. Unhealed bone fracture or wound for long time;

10. Patients with active hepatitis B virus or hepatitis C virus infection;

11. Patients who received systemic antibiotic treatment of serious infections;

12. Pregnant and lactational woman or patients do not receive contraception;

13. Patients who are prone to bleed or use anticoagulant drugs.

14. Patients who have other uncured malignant tumors.

15. 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;

16. 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.;

17. Known history of hypersensitivity to apatinib or any of it components.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Apatinib
Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)
• Irinotecan
Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Chest Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of treatment	time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib	two years
Secondary	progress free survival and overall survival	Secondary study endpoint	two years