<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02980809</url>
  </required_header>
  <id_info>
    <org_study_id>gsk-001</org_study_id>
    <nct_id>NCT02980809</nct_id>
  </id_info>
  <brief_title>Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer</brief_title>
  <official_title>Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Hospitals affiliated to the China PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Hospitals affiliated to the China PLA General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether topotecan plus apatinib are superior to&#xD;
      topotecan alone as second-line therapy in small-cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small-cell lung cancer (SCLC) is an aggressive tumor and most patients experienced relapse or&#xD;
      progression after standard chemotherapy. Topotecan is active as second-line therapy for SCLC&#xD;
      patients. However, even in sensitive patients, only 20% response rate and a median time to&#xD;
      progression of 12 weeks are observed. New therapeutic options in SCLC are needed. Apatinib is&#xD;
      a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor&#xD;
      receptor 2. It has been approved in patients with advanced gastric cancer refractory to two&#xD;
      or more lines of prior chemotherapy. The efficacy of apatinib in SCLC is unknown. The purpose&#xD;
      of this study is to determine whether topotecan plus apatinib are superior to topotecan alone&#xD;
      as second-line therapy in small-cell lung cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2017</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0</measure>
    <time_frame>1 year</time_frame>
    <description>Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Apatinib and topotecan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topotecan</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <arm_group_label>Apatinib and topotecan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topotecan</intervention_name>
    <arm_group_label>Apatinib and topotecan</arm_group_label>
    <arm_group_label>Topotecan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  limited or extensive-stage SCLC who had failed to first-line therapy&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status ≤2&#xD;
&#xD;
          -  at least one measurable lesion as defined by RECIST (version 1.1)&#xD;
&#xD;
          -  at least one measurable lung tumor lesion&#xD;
&#xD;
          -  WBC count ≥3,500/μL, neutrophils ≥1,500μL, platelets ≥100,000μL, hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
          -  AST, and ALT ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with&#xD;
             liver metastases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  symptomatic CNS metastases&#xD;
&#xD;
          -  concomitant or previous malignancies within the last 5 years&#xD;
&#xD;
          -  severe comorbidities; prior topotecan therapy&#xD;
&#xD;
          -  hypersensitivity or other contraindication to the study drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Min-hang Zhou</last_name>
    <phone>86-10-66848733</phone>
    <email>zhou_minhang@163.com</email>
  </overall_contact>
  <reference>
    <citation>O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cucevia B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. doi: 10.1200/JCO.2006.06.5821.</citation>
    <PMID>17135646</PMID>
  </reference>
  <reference>
    <citation>Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998. Erratum In: J Clin Oncol. 2007 Aug 1;25(22):3387.</citation>
    <PMID>17513814</PMID>
  </reference>
  <reference>
    <citation>Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.</citation>
    <PMID>26884585</PMID>
  </reference>
  <reference>
    <citation>Fruh M, De Ruysscher D, Popat S, Crino L, Peters S, Felip E; ESMO Guidelines Working Group. Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi99-105. doi: 10.1093/annonc/mdt178. Epub 2013 Jun 27. No abstract available.</citation>
    <PMID>23813929</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Hospitals affiliated to the China PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Min-hang Zhou</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
    <mesh_term>Topotecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980809
org study id: gsk-001
nct id: NCT02980809
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether topotecan plus apatinib are superior to
      topotecan alone as second-line therapy in small-cell lung cancer.
Small-cell lung cancer (SCLC) is an aggressive tumor and most patients experienced relapse or
      progression after standard chemotherapy. Topotecan is active as second-line therapy for SCLC
      patients. However, even in sensitive patients, only 20% response rate and a median time to
      progression of 12 weeks are observed. New therapeutic options in SCLC are needed. Apatinib is
      a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor
      receptor 2. It has been approved in patients with advanced gastric cancer refractory to two
      or more lines of prior chemotherapy. The efficacy of apatinib in SCLC is unknown. The purpose
      of this study is to determine whether topotecan plus apatinib are superior to topotecan alone
      as second-line therapy in small-cell lung cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 1 year
measure: Response rate
time frame: 1 year
measure: Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0
time frame: 1 year
description: Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0
arm group label: Apatinib and topotecan
arm group type: Experimental
description: Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.
arm group label: Topotecan
arm group type: Placebo Comparator
description: Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.
intervention type: Drug
intervention name: Apatinib
arm group label: Apatinib and topotecan
intervention type: Drug
intervention name: Topotecan
arm group label: Apatinib and topotecan
arm group label: Topotecan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Min-hang Zhou
phone: 86-10-66848733
email: zhou_minhang@163.com
citation: O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cucevia B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. doi: 10.1200/JCO.2006.06.5821.
PMID: 17135646
citation: Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998. Erratum In: J Clin Oncol. 2007 Aug 1;25(22):3387.
PMID: 17513814
citation: Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
PMID: 26884585
citation: Fruh M, De Ruysscher D, Popat S, Crino L, Peters S, Felip E; ESMO Guidelines Working Group. Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi99-105. doi: 10.1093/annonc/mdt178. Epub 2013 Jun 27. No abstract available.
PMID: 23813929
responsible party type: Principal Investigator
investigator affiliation: First Hospitals affiliated to the China PLA General Hospital
investigator full name: Min-hang Zhou
investigator title: doctor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Apatinib
mesh term: Topotecan
sharing ipd: Undecided