- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389087
Study of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer
July 8, 2020 updated by: Henan Cancer Hospital
Single Arm, Exploratory and Open Phase II Clinical Trial of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathological diagnosis of small cell lung cancer.
- ≥ 18 and ≤ 75 years of age.
- According to RESCIST1.1 standard, there are evaluable target lesions.
- Has received second-line standard treatment of recurrent or metastatic extensive stage small cell lung cancer.
- Life expectancy of more than 3 months.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 2.
- 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.
- 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.
- Signed the informed consent form prior to patient entry.
Exclusion Criteria:
- 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);
- 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;
- 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%;
- 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;
- 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;
- 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.
- 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);
- Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g;
- Previously used anti-angiogenic drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Apatinib and Etoposide Capsule
|
Apatinib 250mg/qd,po, A course of treatment need 28 days.
Etoposide Capsule 25mg/d,po, from day 1-day 21.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival(OS)
Time Frame: up to 2 year
|
From date of randomization until the date of death from any cause
|
up to 2 year
|
Objective Response Rate (ORR)
Time Frame: up to 1 year
|
From date of randomization until the date of death from any cause
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Qiming Wang, Henan Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2017
Primary Completion (Actual)
November 1, 2019
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
December 22, 2017
First Submitted That Met QC Criteria
December 24, 2017
First Posted (Actual)
January 3, 2018
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Etoposide
- Apatinib
Other Study ID Numbers
- AHEAD-HNP053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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