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The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02733107
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Xueqin Yang, Third Military Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Apatinib Drug: Etoposide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Apatinib+Etoposide
Apatinib combined with Etoposide
Drug: Apatinib
Apatinib, 250mg daily, po, continue until disease progression

Drug: Etoposide
Etoposide, 50mg daily, po, day 1 to day 20, repeat Q 4 weeks until disease progression
Other Name: VP-16




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Overall survival [ Time Frame: the first day of treatment to death or last survival confirm date,up to 24 months ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02733107


Contacts
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Contact: Xueqin Yang, PHD 86-23-68757151 yangxueqin@hotmail.com

Locations
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China, Chongqing
Daping Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Xueqin Yang, PH.D.    86-23-68757151    yangxueqin@hotmail.com   
Principal Investigator: Xueqin Yang, PH.D.         
Sponsors and Collaborators
Third Military Medical University

Publications of Results:
Other Publications:
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Responsible Party: Xueqin Yang, PHD, Third Military Medical University
ClinicalTrials.gov Identifier: NCT02733107     History of Changes
Other Study ID Numbers: ACEL
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xueqin Yang, Third Military Medical University:
Non-small Cell Lung Cancer
Apatinib
Etoposide
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide
Etoposide phosphate
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors