- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02733107
The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer
April 10, 2016 updated by: Xueqin Yang, Third Military Medical University
The Efficacy and Safety of Apatinib Combined With Etoposide in Advanced Non-small Cell Lung Cancer Patients Failed to Previous at Least 2rd Line Treatments
The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments.
Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2).
Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline.
The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments.
Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
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 Contact
- Name: Xueqin Yang, PHD
- Phone Number: 86-23-68757151
- Email: yangxueqin@hotmail.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Recruiting
- Daping Hospital, Third Military Medical University
-
Contact:
- Xueqin Yang, PH.D.
- Phone Number: 86-23-68757151
- Email: yangxueqin@hotmail.com
-
Principal Investigator:
- Xueqin Yang, PH.D.
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Obtain of informed consent.
- Histologically or cytologically confirmed non-small cell lung cancer.
- World Health Organization (WHO) performance status (PS) of 0 to 2.
- Measurable lesions as defined by RECIST criteria.
- Second-line or more treatments.
- Wild type of epidermal-growth-factor receptor (EGFR).
- Life expectancy ≥12 weeks.
Organ functions normal, as defined below, within two weeks of randomization:
• Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN.
- Females of child-bearing potential must have negative serum pregnancy test.
- Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
Exclusion Criteria:
- Small cell lung cancer.
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Uncontrolled hypertension.
- Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy.
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- Hemoptysis, more than 2.5ml daily.
- Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
- Unhealed bone fracture or wound for long time.
- Received big surgery, had bone fracture or ulcer in 4 weeks.
- Urine protein≥++, or urine protein in 24 hours≥1.0g.
- Pregnant or lactating woman.
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 |
---|---|
Other: Apatinib+Etoposide
Apatinib combined with Etoposide
|
Apatinib, 250mg daily, po, continue until disease progression
Etoposide, 50mg daily, po, day 1 to day 20, repeat Q 4 weeks until disease progression
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: evaluated in 24 months since the treatment began
|
the first day of treatment to the date that disease progression is reported
|
evaluated in 24 months since the treatment began
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: tumor assessment every 6-8 weeks since the treatment began,up to 24 months
|
the ratio between the number of responders and number of patients assessable for tumor response
|
tumor assessment every 6-8 weeks since the treatment began,up to 24 months
|
Overall survival
Time Frame: the first day of treatment to death or last survival confirm date,up to 24 months
|
the first day of treatment to death or last survival confirm date,up to 24 months
|
|
Side effects
Time Frame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zhou C, Wu YL, Chen G, Liu X, Zhu Y, Lu S, Feng J, He J, Han B, Wang J, Jiang G, Hu C, Zhang H, Cheng G, Song X, Lu Y, Pan H, Zheng W, Yin AY. BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Jul 1;33(19):2197-204. doi: 10.1200/JCO.2014.59.4424. Epub 2015 May 26.
- Okamoto I, Miyazaki M, Takeda M, Terashima M, Azuma K, Hayashi H, Kaneda H, Kurata T, Tsurutani J, Seto T, Hirai F, Konishi K, Sarashina A, Yagi N, Kaiser R, Nakagawa K. Tolerability of nintedanib (BIBF 1120) in combination with docetaxel: a phase 1 study in Japanese patients with previously treated non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):346-52. doi: 10.1097/JTO.0000000000000395.
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
March 1, 2016
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
April 5, 2016
First Submitted That Met QC Criteria
April 8, 2016
First Posted (Estimate)
April 11, 2016
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 10, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- 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
- ACEL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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