<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/NCT01697605</url>
  </required_header>
  <id_info>
    <org_study_id>CBGJ398X1101</org_study_id>
    <nct_id>NCT01697605</nct_id>
  </id_info>
  <brief_title>A Phase I Study of Oral BGJ398 in Asian Patients</brief_title>
  <official_title>A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate safety and tolerability to determine the Maximum tolerated dose&#xD;
      (MTD) and/or Recommended dose (RD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398,&#xD;
      administered on a continuous once and/or twice daily schedule.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2012</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate and category of dose limiting toxicities (DLTs)</measure>
    <time_frame>First cycle of 28 days</time_frame>
    <description>Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)</measure>
    <time_frame>From within 21 days of first treatment to 28 days after treatment discontinuation</time_frame>
    <description>To characterize the safety and tolerability of oral BGJ398</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hematology and chemistry values</measure>
    <time_frame>From baseline to 28 days after treatment discontinuation</time_frame>
    <description>hematology and chemistry values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessments of physical examinations, vital signs and electrocardiograms (ECGs)</measure>
    <time_frame>Participants will be followed for the duration of treatment, an expected average of 24 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time vs. concentration profiles</measure>
    <time_frame>1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks</time_frame>
    <description>To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary anti-tumor activity</measure>
    <time_frame>Participants will be followed for the duration of treatment, an expected average of 24 weeks.</time_frame>
    <description>Assessed based on RECIST version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR)</measure>
    <time_frame>Participants will be followed for the duration of treatment, an expected average of 24 weeks.</time_frame>
    <description>Assessed by investigator per RECIST version 1.1. BOR is the best response recorded until disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>Participants will be followed for the duration of treatment, an expected average of 24 weeks.</time_frame>
    <description>Assessed by investigator per RECIST version 1.1. ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.</time_frame>
    <description>PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of all Adverse Events (AEs)</measure>
    <time_frame>From within 21 days of first treatment to 28 days after treatment discontinuation</time_frame>
    <description>To characterize the safety and tolerability of oral BGJ398</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Serious Advers Events (SAEs)</measure>
    <time_frame>From within 21 days of first treatment to 28 days after treatment discontinuation</time_frame>
    <description>To characterize the safety and tolerability of oral BGJ398</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of all Adverse Events (AEs)</measure>
    <time_frame>From within 21 days of first treatment to 28 days after treatment discontinuation</time_frame>
    <description>To characterize the safety and tolerability of oral BGJ398</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of all Serious Advers Events (SAEs)</measure>
    <time_frame>From within 21 days of first treatment to 28 days after treatment discontinuation</time_frame>
    <description>To characterize the safety and tolerability of oral BGJ398</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Tumor With Alterations of the FGF-R</condition>
  <arm_group>
    <arm_group_label>BGJ398</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BGJ398</intervention_name>
    <arm_group_label>BGJ398</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced solid tumors with FGF-R alteration&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS)&#xD;
             disease&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply.&#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_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>51000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guangzhou</city>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Nagoya-city</city>
        <state>Aichi</state>
        <zip>466-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East (NCEE)</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sayama</city>
        <state>Osaka</state>
        <zip>589 8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Sunto-gun</city>
        <state>Shizuoka</state>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17561</url>
    <description>Results for CBGJ398X1101 can be found on the Novartis Clinical Trials Results website</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>December 6, 2020</last_update_submitted>
  <last_update_submitted_qc>December 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infigratinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01697605
org study id: CBGJ398X1101
nct id: NCT01697605
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate safety and tolerability to determine the Maximum tolerated dose
      (MTD) and/or Recommended dose (RD).
This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398,
      administered on a continuous once and/or twice daily schedule.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence rate and category of dose limiting toxicities (DLTs)
time frame: First cycle of 28 days
description: Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
measure: Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
description: To characterize the safety and tolerability of oral BGJ398
measure: Changes in hematology and chemistry values
time frame: From baseline to 28 days after treatment discontinuation
description: hematology and chemistry values
measure: Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
measure: Time vs. concentration profiles
time frame: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
description: To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites
measure: Preliminary anti-tumor activity
time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
description: Assessed based on RECIST version 1.1
measure: Best overall response (BOR)
time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
description: Assessed by investigator per RECIST version 1.1. BOR is the best response recorded until disease progression.
measure: Overall response rate (ORR)
time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
description: Assessed by investigator per RECIST version 1.1. ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).
measure: Progression-free survival (PFS)
time frame: From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
description: PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.
measure: Duration of all Adverse Events (AEs)
time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
description: To characterize the safety and tolerability of oral BGJ398
measure: Duration of Serious Advers Events (SAEs)
time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
description: To characterize the safety and tolerability of oral BGJ398
measure: Severity of all Adverse Events (AEs)
time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
description: To characterize the safety and tolerability of oral BGJ398
measure: Severity of all Serious Advers Events (SAEs)
time frame: From within 21 days of first treatment to 28 days after treatment discontinuation
description: To characterize the safety and tolerability of oral BGJ398
arm group label: BGJ398
arm group type: Experimental
description: Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.
intervention type: Drug
intervention name: BGJ398
arm group label: BGJ398
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Japan
url: https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17561
description: Results for CBGJ398X1101 can be found on the Novartis Clinical Trials Results website
responsible party type: Sponsor
mesh term: Infigratinib
sharing ipd: No