<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/NCT03834220</url>
  </required_header>
  <id_info>
    <org_study_id>Debio 1347-201</org_study_id>
    <secondary_id>2018-003584-53</secondary_id>
    <nct_id>NCT03834220</nct_id>
  </id_info>
  <brief_title>Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)</brief_title>
  <official_title>A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Debiopharm International SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Caris Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Optimal Research (Just In Time sites)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Debiopharm International SA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the efficacy of Debio 1347 in terms of&#xD;
      objective response rate (ORR) in participants with solid tumors harboring fibroblast growth&#xD;
      factor receptor (FGFR)1-3 gene fusion/rearrangement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to lower antitumor activity than expected&#xD;
  </why_stopped>
  <start_date type="Actual">March 22, 2019</start_date>
  <completion_date type="Actual">January 4, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to 44 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 44 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 44 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Concentration (Ctrough) of Debio 1347</measure>
    <time_frame>Up to Cycle 2 (each cycle is 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCt) of Debio 1347</measure>
    <time_frame>Up to Cycle 2 (each cycle is 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of Debio 1347 plasma concentration and QTcF</measure>
    <time_frame>Up to 44 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Debio 1347</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Debio 1347</intervention_name>
    <description>80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.</description>
    <arm_group_label>Debio 1347</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cytologically or histologically confirmed advanced solid tumor&#xD;
&#xD;
          -  Radiographic progression on prior systemic therapy; prior localized therapy (i.e.,&#xD;
             radiation, ablation, embolization) is allowed provided radiographic progression&#xD;
             out-of-field or in the treatment, field is shown&#xD;
&#xD;
          -  Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene&#xD;
             fusion/rearrangement potentially leading to a functional FGFR aberrant protein,&#xD;
             identified through local and/or central molecular assay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity to any of the excipients in the Debio 1347 formulation&#xD;
&#xD;
          -  History and/or current evidence of ectopic mineralization/calcification, including but&#xD;
             not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting&#xD;
             calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon&#xD;
             calcifications&#xD;
&#xD;
          -  Administration of any investigational agent within 2 weeks prior to initial dosing&#xD;
             with Debio 1347 (3 weeks for immune checkpoint inhibitors)&#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>Ironwood Cancer &amp; Research Centers - Scottsdale</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moores UCSD Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarcoma Oncology Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute, Inc</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Graham Brown Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>10202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University Cancer Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The John Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Health, LLC.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center - James Cancer Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTCA Cancer Treatment Centers</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Penn - Allegheny Oncology Network</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospitals &amp; Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson/Seattle Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Highlands Private Hospital</name>
      <address>
        <city>Bowral</city>
        <zip>NSW 2576</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula and Southeast Oncology (PASO)</name>
      <address>
        <city>Frankston</city>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linear Clinical Research, B Block Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Flynn Private Hospital</name>
      <address>
        <city>Tugun</city>
        <zip>4224</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH - Universitätsklinikum der PMU Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landesklinikum Wiener Neustadt</name>
      <address>
        <city>Wiener Neustadt</city>
        <zip>2700</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Caridade de Ijuí, Avenida David J Martins</name>
      <address>
        <city>Ijuí</city>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Rio Grande</city>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia</name>
      <address>
        <city>Santo André</city>
        <zip>09060-870</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo</name>
      <address>
        <city>São Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT - Dobrich</name>
      <address>
        <city>Dobrich</city>
        <zip>9300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complex Oncological Center - Plovdiv, EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Serdika&quot;, EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1632</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Varazdin</name>
      <address>
        <city>Varaždin</city>
        <zip>42000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre, Sestre Milosrdnice</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice u sv. Anny v Brne</name>
      <address>
        <city>Brno</city>
        <zip>656 91</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Králové</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>775 20</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice</name>
      <address>
        <city>Prague</city>
        <zip>14000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Kralovske Vinohrady</name>
      <address>
        <city>Praha</city>
        <zip>100 34</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ålborg Universitets Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Docrates Syöpäsairaala</name>
      <address>
        <city>Helsinki</city>
        <zip>00180</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO - Site Paul Papin</name>
      <address>
        <city>Angers</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Sud - Hôpital Haut Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO - Site René Gauducheau</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Laiko</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens of Chest Diseases &quot;SOTIRIA&quot;</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Alexandra&quot;</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Ioannina</name>
      <address>
        <city>Ioánnina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital, Department of Oncology Medical office</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13605</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital (SNUH)</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital, CRC room, Clinical Trial Center</name>
      <address>
        <city>Suwon</city>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haga Ziekenhuis</name>
      <address>
        <city>Den Haag</city>
        <zip>2545 AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiumhospitalet, Montebello</name>
      <address>
        <city>Oslo</city>
        <zip>0310</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cebu Doctors' University Hospital (CDUH), Research Office</name>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory</name>
      <address>
        <city>Ermita</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center, Human Cancer Biobank Research Center</name>
      <address>
        <city>Quezon City</city>
        <zip>1112</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu</name>
      <address>
        <city>Poznań</city>
        <zip>60-355</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research</name>
      <address>
        <city>Warszawa</city>
        <zip>02-106</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii-Instytut im.M.Sklodowskiej Curie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Delta Health Care S.R.L</name>
      <address>
        <city>Bucuresti</city>
        <zip>014142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Medisprof S.R.L.</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400641</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Centrul de Oncologie Sf. Nectarie S.R.L.</name>
      <address>
        <city>Craiova</city>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Oncocenter Oncologie Clinica S.R.L.</name>
      <address>
        <city>Timişoara</city>
        <zip>300166</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBIH of Arkhangelsk region &quot;Arkhangelsk Clinical Oncological Dispensary&quot;</name>
      <address>
        <city>Arkhangel'sk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TSBHI &quot;Altai Territorial oncological dispensary&quot;</name>
      <address>
        <city>Barnaul</city>
        <zip>656049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Evimed</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454048</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBSI &quot;Russian Oncological Scientific Center n.a. N.N. Blokhin&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BHI of Omsk region &quot;Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomsk Research Instutite of Oncology</name>
      <address>
        <city>Tomsk</city>
        <zip>634028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore National Cancer Center (SNCC)</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital, Communicable Disease Centre</name>
      <address>
        <city>Singapore</city>
        <zip>308440</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral Oncologico Clara Campal</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shuang Ho Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>23561</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital, The Radiation Oncology Department</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital (TMUH)</name>
      <address>
        <city>Taipei</city>
        <zip>11031</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital, Medical Science &amp; Technology Building</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkou Chang-Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI V.T. Zaycev Institute of general &amp; urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery</name>
      <address>
        <city>Kharkiv</city>
        <zip>61018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-profit Enterprise Regional Center of Oncology</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Greece</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <disposition_first_submitted>December 24, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>December 24, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 28, 2021</disposition_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</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>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03834220
org study id: Debio 1347-201
secondary id: 2018-003584-53
nct id: NCT03834220
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to assess the efficacy of Debio 1347 in terms of
      objective response rate (ORR) in participants with solid tumors harboring fibroblast growth
      factor receptor (FGFR)1-3 gene fusion/rearrangement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Up to 44 months
measure: Duration of Response (DOR)
time frame: Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)
measure: Disease Control Rate (DCR)
time frame: Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)
measure: Progression-Free Survival (PFS)
time frame: Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months)
measure: Overall Survival (OS)
time frame: Up to 44 months
measure: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: Up to 44 months
measure: Trough Concentration (Ctrough) of Debio 1347
time frame: Up to Cycle 2 (each cycle is 28 days)
measure: Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCt) of Debio 1347
time frame: Up to Cycle 2 (each cycle is 28 days)
measure: Correlation of Debio 1347 plasma concentration and QTcF
time frame: Up to 44 months
arm group label: Debio 1347
arm group type: Experimental
description: Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.
intervention type: Drug
intervention name: Debio 1347
description: 80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.
arm group label: Debio 1347
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Austria
country: Brazil
country: Bulgaria
country: Croatia
country: Czechia
country: Denmark
country: Finland
country: France
country: Greece
country: Korea, Republic of
country: Netherlands
country: Norway
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: Singapore
country: Spain
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No