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Study of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03389087
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
The purpose of this study is to confirm the safety and efficacy of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Apatinib + Etoposide Capsule Phase 2

Detailed Description:
Small cell lung cancer is a very aggressive cancer, often accompanied by distant metastases, with a poor prognosis. 5-year survival rate of less than 5%, untreated patients with an average survival of only 2-4 months. The investigators consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients. The investigators designed the study to explore the possibility of apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm, Exploratory and Open Phase II Clinical Trial of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Apatinib + Etoposide Capsule
Apatinib + Etoposide Capsule
Drug: Apatinib + Etoposide Capsule
Apatinib 250mg/qd,po, A course of treatment need 28 days. Etoposide Capsule 25mg/d,po, from day 1-day 21.



Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of first documented progression or date of death from any cause


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause

  2. Objective Response Rate (ORR) [ Time Frame: up to 1 year ]
    From date of randomization until the date of death from any cause



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathological diagnosis of small cell lung cancer.
  2. ≥ 18 and ≤ 75 years of age.
  3. According to RESCIST1.1 standard, there are evaluable target lesions.
  4. Has received second-line standard treatment of recurrent or metastatic extensive stage small cell lung cancer.
  5. Life expectancy of more than 3 months.
  6. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 2.
  7. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.25×ULN, Cr clearance ≥ 45 mL/min.
  8. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.
  9. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

  1. Active brain metastases, meningococcal meningitis, patients with spinal cord compression, or imaging at CT or MRI examination revealed brain or pia mater disease(Patients who have completed treatment and whose symptoms are stable in the first 21 days of randomization may be enrolled in the study but may be diagnosed as having no intracerebral hemorrhage by MRI, CT or venography);
  2. Imaging (CT or MRI) showed that the tumor lesions were ≤ 5 mm from the major vessels or there was a central tumor invading local macrovascular;
  3. Imaging (CT or MRI) showed significant cavitary or necrotic lung tumors, uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA standards, Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasound examination prompted left ventricular ejection Score (LVEF) <50%;
  4. Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment;Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
  5. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above;
  6. 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.
  7. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (Including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening(Such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism and so on);
  8. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g;
  9. Previously used anti-angiogenic drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389087


Contacts
Contact: Qiming Wang 13783590691 qimingwang1006@126.com

Locations
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Qiming Wang    13783590691    qimingwang1006@126.com   
Sponsors and Collaborators
Henan Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Qiming Wang Henan Cancer Hospital

Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03389087     History of Changes
Other Study ID Numbers: AHEAD-HNP053
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action