<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/NCT02200757</url>
  </required_header>
  <id_info>
    <org_study_id>ALDOXORUBICIN-P2-SCLC-01</org_study_id>
    <nct_id>NCT02200757</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer</brief_title>
  <official_title>A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CytRx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CytRx</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to&#xD;
      topotecan in subjects with metastatic small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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 (PFS)</measure>
    <time_frame>24 months</time_frame>
    <description>PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>36 months</time_frame>
    <description>Overall survival is defined as the time from randomization to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Measures</measure>
    <time_frame>24 months</time_frame>
    <description>The safety of aldoxorubicin compared to topotecan in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Metastatic Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Aldoxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Topotecan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aldoxorubicin</intervention_name>
    <description>230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.</description>
    <arm_group_label>Aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topotecan</intervention_name>
    <description>1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs</description>
    <arm_group_label>Topotecan</arm_group_label>
    <other_name>Hycamtin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years male or female.&#xD;
&#xD;
          2. Histological confirmation of SCLC.&#xD;
&#xD;
          3. Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is&#xD;
             incurable by either surgery or radiation.&#xD;
&#xD;
          4. Capable of providing informed consent and complying with trial procedures.&#xD;
&#xD;
          5. ECOG PS 0-2.&#xD;
&#xD;
          6. Life expectancy &gt;8 weeks.&#xD;
&#xD;
          7. Measurable tumor lesions according to RECIST 1.1 criteria.[22]&#xD;
&#xD;
          8. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year,&#xD;
             surgically sterile, or practicing adequate birth control methods) for the duration of&#xD;
             the study. (Adequate contraception includes: oral contraception, implanted&#xD;
             contraception, intrauterine device implanted for at least 3 months, or barrier method&#xD;
             in conjunction with spermicide.)&#xD;
&#xD;
          9. Males and their female partner(s) of child-bearing potential must use 2 forms of&#xD;
             effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the&#xD;
             last menstrual period of the female partner during the study treatment and for 6&#xD;
             months after the final dose of study treatment.&#xD;
&#xD;
         10. Women of child bearing potential must have a negative serum or urine pregnancy test at&#xD;
             the Screening Visit and be non-lactating.&#xD;
&#xD;
         11. Accessibility to the site that ensures the subject will be able to keep all&#xD;
             study-related appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior exposure to &gt;375 mg/m2 of doxorubicin or liposomal doxorubicin.&#xD;
&#xD;
          2. Prior treatment with topotecan.&#xD;
&#xD;
          3. Palliative surgery and/or radiation treatment &lt; 21 days prior to date of&#xD;
             randomization.&#xD;
&#xD;
          4. Exposure to any investigational agent within 30 days of date of randomization.&#xD;
&#xD;
          5. Exposure to any systemic chemotherapy within 21 days of date of randomization.&#xD;
&#xD;
          6. Active (symptomatic) central nervous system (CNS) metastasis.&#xD;
&#xD;
          7. History of other malignancies except cured basal cell carcinoma, cutaneous squamous&#xD;
             cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of&#xD;
             the cervix unless documented free of cancer for ≥3 years.&#xD;
&#xD;
          8. Laboratory values: Screening serum creatinine &gt;1.5×upper limit of normal (ULN),&#xD;
             alanine aminotransferase (ALT) &gt;3×ULN or &gt;5×ULN if liver metastases are present, total&#xD;
             bilirubin &gt;2×ULN, absolute neutrophil count (ANC) &lt;1,500/mm3, platelet concentration&#xD;
             &lt;100,000/mm3, hemoglobin &lt;9 g/dL, albumin &lt;2 gm/dL.&#xD;
&#xD;
          9. Anion gap &gt; 16 meq/L or arterial blood pH &lt; 7.30.&#xD;
&#xD;
         10. Clinically evident congestive heart failure (CHF) &gt; class II of the New York Heart&#xD;
             Association (NYHA) guidelines (Appendix D).&#xD;
&#xD;
         11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence&#xD;
             of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V&#xD;
             (Appendix F).&#xD;
&#xD;
         12. Baseline QTc &gt;470 msec measured by Fridericia's formula (QTcF) and/or previous history&#xD;
             of QT prolongation while taking other medications. Concomitant use of medications&#xD;
             associated with a high incidence of QT prolongation is not allowed.&#xD;
&#xD;
         13. History or signs of active coronary artery disease with angina pectoris within the&#xD;
             last 6 months.&#xD;
&#xD;
         14. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection&#xD;
             fraction (LVEF) below the institution's lower limit of predicted normal.&#xD;
&#xD;
         15. Known history of HIV infection.&#xD;
&#xD;
         16. Active, clinically significant serious infection requiring treatment with antibiotics,&#xD;
             anti-virals or anti-fungals.&#xD;
&#xD;
         17. Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar,&#xD;
             ketoconazole, ritonavir, saquinavir.&#xD;
&#xD;
         18. Major surgery within 30 days prior to date of randomization.&#xD;
&#xD;
         19. Substance abuse or any condition that might interfere with the subject's participation&#xD;
             in the study or in the evaluation of the study results.&#xD;
&#xD;
         20. Any condition that is unstable and could jeopardize the subject's participation in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia Martin</last_name>
      <phone>910-423-2276</phone>
      <email>cynthia.martin@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Alain Mita, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City of Hope Medical Group</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>New Patient Services</last_name>
      <phone>626-256-4673</phone>
    </contact>
    <investigator>
      <last_name>Marianna Koczywas, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Cancer Specialists of North Florida-Fleming Island</name>
      <address>
        <city>Fleming Island</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Rammage</last_name>
      <phone>904-538-4488</phone>
      <email>research@CSNF.US</email>
    </contact>
    <investigator>
      <last_name>Augusto Villegas, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hematoloy Oncology Associates</name>
      <address>
        <city>Port St. Lucie</city>
        <state>Florida</state>
        <zip>34982</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Centers, P.C.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Lee</last_name>
      <phone>770-281-5131</phone>
      <email>mlee@ngoc.com</email>
    </contact>
    <investigator>
      <last_name>Robert Hermann, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>James Graham Brown Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Schoenbachler</last_name>
      <phone>502-562-3429</phone>
      <email>jmgoyn01@louisville.edu</email>
    </contact>
    <investigator>
      <last_name>Goetz Kloecker, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Jefferson Medical Center, Cancer Center</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Bay Hematology Oncology</name>
      <address>
        <city>Easton</city>
        <state>Maryland</state>
        <zip>21601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine, Department of Internal Medicine</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Oncology Hermatology Care, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patient Hotline</last_name>
      <phone>877-691-7274</phone>
      <email>askSarah@scresearch.net</email>
    </contact>
    <investigator>
      <last_name>David Waterhouse, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwest CCOP Kaiser Permanente</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rhonda Stephenson</last_name>
      <phone>503-331-6537</phone>
      <email>rhonda.stephenson@kpchr.org</email>
    </contact>
    <investigator>
      <last_name>Abdul Hai Mansoor, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Cancer Institute</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Austin</last_name>
      <phone>772-408-5158</phone>
      <email>haustin@hemoncfl.com</email>
    </contact>
    <investigator>
      <last_name>Chandra Belani, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology</name>
      <address>
        <city>Cattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hotline</last_name>
      <phone>877-691-7274</phone>
      <email>askSarah@scresearch.net</email>
    </contact>
    <investigator>
      <last_name>Davey Daniel, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tennessee Cancer Specialists</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susie Owen</last_name>
      <phone>865-934-2672</phone>
      <email>sowenby@biomed-research.com</email>
    </contact>
    <investigator>
      <last_name>Russel DeVore, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daphne Hubbard</last_name>
      <phone>615-524-4032</phone>
      <email>daphne.hubbard@scresearch.net</email>
    </contact>
    <investigator>
      <last_name>Ray Page, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Koranyi National Institute of TBC and Pulmonologyhhy</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katalin Udud</last_name>
      <phone>+36 (1) 391 3233</phone>
      <email>katiudud@freemail.hu</email>
    </contact>
    <investigator>
      <last_name>Katalin Udud, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Koranyi National Institute of TBC and Pulmonology</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erzsebet Juhasz</last_name>
      <phone>+36 (1) 391 3277</phone>
      <email>juhasz@koranyi.hu</email>
    </contact>
    <investigator>
      <last_name>Ildiko Horvath, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Debrecen, Medical and Health Science Center, Department of Pulmonology</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Szilasi</last_name>
      <phone>+36 (52) 414 222</phone>
      <email>mszilasi@dote.hu</email>
    </contact>
    <investigator>
      <last_name>Maria Szilasi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology</name>
      <address>
        <city>Nyiregyhaza</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Szabo</last_name>
      <phone>+36 (42) 403 266</phone>
      <email>dr.szabo.peter@josa.hu</email>
    </contact>
    <investigator>
      <last_name>Peter Szabo, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical Center of the University of Pecs, 1st Department of Internal Medicine</name>
      <address>
        <city>Pecs</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Veronika Sarosi</last_name>
      <email>sarosi.veronika@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Veronika Sarosi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hetenyi Geza Hospital</name>
      <address>
        <city>Szolnok, Jasz-Nagykun-Szolnok</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tibor Csoszi</last_name>
      <phone>+36 (56) 503 603</phone>
      <email>dr.cstibor@freemail.hu</email>
    </contact>
    <investigator>
      <last_name>Tibor Csoszi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bartomeu Massuti</last_name>
      <phone>34 965 933 513</phone>
      <email>bmassutis@seom.org</email>
    </contact>
    <investigator>
      <last_name>Bartomeu Massuti, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noemi Reguart</last_name>
      <phone>0034 93 227 54 02 ext 2811</phone>
      <email>NREGUART@clinic.ub.es</email>
    </contact>
    <investigator>
      <last_name>Noemi Reguart, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quiron-Dexeus (IOR)</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafael Rosell</last_name>
      <phone>34 93 546 0135</phone>
      <email>rrosell@iconcologia.net</email>
    </contact>
    <investigator>
      <last_name>Rafael Rosell, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alejandro Navarro</last_name>
      <phone>+34 (93) 274 6085</phone>
      <email>alnavarro@vhebron.net</email>
    </contact>
    <investigator>
      <last_name>Alejandro Navarro, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natlia Fernandez</last_name>
      <phone>34 982 296459</phone>
      <email>Natalia.fernandez.nunez@sergas.es</email>
    </contact>
    <investigator>
      <last_name>Natlia Fernandez, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General University Hospital Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ramon Garcia Gomez</last_name>
      <phone>+34 (91) 426 9393</phone>
      <email>ramon.garcia@salud.madrid.org</email>
    </contact>
    <investigator>
      <last_name>Ramon Garcia Gomez, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariano Provencio Pulla</last_name>
      <phone>+34 (91) 1917418</phone>
      <email>mprovencio.ensayosclinicos@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Mariano Provencio Pulla, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Foundation Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Domine Gomez</last_name>
      <phone>+34 (91) 549 4908</phone>
      <email>mdomine@fjd.es</email>
    </contact>
    <investigator>
      <last_name>Manuel Domine Gomez, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier De Castro</last_name>
      <phone>+34 (91) 727 7516</phone>
      <email>jcastro.hulp@salud.madrid.org</email>
    </contact>
    <investigator>
      <last_name>Javier De Castro, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanesa Gutierrez</last_name>
      <phone>34 951 291 425</phone>
      <email>vanesa_gutierrez78@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Vanesa Gutierrez, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Virgen de Valme</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reyes Bernabe Caro</last_name>
      <phone>34 95 501 9273</phone>
      <email>reyesbernab@yahoo.es</email>
    </contact>
    <investigator>
      <last_name>Reyes Bemabe Caro, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Xeral</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Lazaro</last_name>
      <phone>34 986219 766</phone>
      <email>Martin.Lazaro.Quintela@sergas.es</email>
    </contact>
    <investigator>
      <last_name>Martin Lazaro, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>August 17, 2016</last_update_submitted>
  <last_update_submitted_qc>August 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Topotecan</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02200757
org study id: ALDOXORUBICIN-P2-SCLC-01
nct id: NCT02200757
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to
      topotecan in subjects with metastatic small cell lung cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS)
time frame: 24 months
description: PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
measure: Overall Survival (OS)
time frame: 36 months
description: Overall survival is defined as the time from randomization to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.
measure: Safety Measures
time frame: 24 months
description: The safety of aldoxorubicin compared to topotecan in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.
arm group label: Aldoxorubicin
arm group type: Experimental
arm group label: Topotecan
arm group type: Active Comparator
intervention type: Drug
intervention name: Aldoxorubicin
description: 230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.
arm group label: Aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: Topotecan
description: 1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs
arm group label: Topotecan
other name: Hycamtin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Hungary
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Topotecan