<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/NCT01725555</url>
  </required_header>
  <id_info>
    <org_study_id>AXL010</org_study_id>
    <nct_id>NCT01725555</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors</brief_title>
  <official_title>A Randomized, Open-label, Phase I, Crossover Study to Assess the Effect of Food on the Bioavailability of AXL1717, in Patients With Advanced Malignant Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Axelar AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Axelar AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect&#xD;
      of food on the bioavailability of AXL1717 including patients with advanced malignant tumors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, crossover, open label, phase I study to assess the effect of food on&#xD;
      the bioavailability of AXL1717 in advanced cancer patients.&#xD;
&#xD;
      A single, oral dose of AXL1717 is to be administered to patients on each of two occasions&#xD;
      that are 7-day apart, in random order: after an overnight fast (fasted treatment) and with a&#xD;
      high-fat or moderate-fat breakfast (fed treatment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient</measure>
    <time_frame>several samples within 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of AXL1717 through adverse event reporting</measure>
    <time_frame>Up to 30 days after last dose of study drug</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Solid Tumors</condition>
  <condition>Hematological Malignancies</condition>
  <arm_group>
    <arm_group_label>Fasted treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fed treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fasted treatment: AXL1717</intervention_name>
    <arm_group_label>Fasted treatment</arm_group_label>
    <arm_group_label>Fed treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fed treatment: AXL1717</intervention_name>
    <arm_group_label>Fasted treatment</arm_group_label>
    <arm_group_label>Fed treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be informed of the nature of the study and have provided written informed consent&#xD;
&#xD;
          2. At least 18 years of age&#xD;
&#xD;
          3. Histologically confirmed diagnosis of advanced solid or hematological malignancy not&#xD;
             amenable to standard treatment.&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 after optimization of&#xD;
             analgesics&#xD;
&#xD;
          5. Life expectancy ≥ 3 months&#xD;
&#xD;
          6. Hematology values: blood leukocyte count ≥ 3.0 x 109/L, blood absolute neutrophil&#xD;
             count ≥ 1.5 x 109/L, blood platelet count ≥ 100 x109/L, hemoglobin ≥ 100 g/L&#xD;
             (transfusions are allowed)&#xD;
&#xD;
          7. Clinical chemistry values: plasma total bilirubin level ≤ 1.5 times the upper limit of&#xD;
             the &quot;normal&quot; range (ULN; i.e. reference), plasma AST or ALT ≤ 1.5 x ULN (≤5 times if&#xD;
             liver metastases have been documented) and plasma creatinine ≤ 1.5 x ULN&#xD;
&#xD;
          8. 12-lead ECG with normal tracings; or changes that are not clinically significant and&#xD;
             do not require medical intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing infection or other major recent or ongoing disease that, according to the&#xD;
             Investigator, poses an unacceptable risk to the patient&#xD;
&#xD;
          2. Known primary or secondary central nervous system malignancy. (Patients with symptoms&#xD;
             suggestive of possible CNS metastasis such as headache, dizziness or focal&#xD;
             neurological deficits should undergo CT or MRI of the brain to rule out CNS&#xD;
             metastasis. Patients who do not have CNS symptoms do not need a CT or MRI of the&#xD;
             brain.)&#xD;
&#xD;
          3. Grade 3 or higher constipation within the past 28 days or grade 2 constipation within&#xD;
             the past 14 days before randomization. (Patients with grade 2 constipation within the&#xD;
             past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal&#xD;
             management of constipation.)&#xD;
&#xD;
          4. Impairment of gastrointestinal (GI) function, GI cancer or GI disease that may&#xD;
             significantly alter the absorption of AXL1717&#xD;
&#xD;
          5. Coexisting uncontrolled medical condition, including active cardiac disease (such as&#xD;
             unstable angina, myocardial infarction within 6 months, or New York Heart Association&#xD;
             Class III/IV congestive heart failure), or significant dementia&#xD;
&#xD;
          6. Hepatic impairment as indicated by abnormalities of transaminases and/or alkaline&#xD;
             phosphatase (AST and/or ALT &gt; 1.5 × upper limit of normal concomitant with alkaline&#xD;
             phosphatase &gt; 2.5 × upper limit of normal, ≤5 times if liver metastases have been&#xD;
             documented)&#xD;
&#xD;
          7. Major surgical procedure within 4 weeks prior to randomization&#xD;
&#xD;
          8. Use of potent inhibitors of CYP2C9 (e.g. Fluconazole) from 3 weeks prior to first&#xD;
             administration of investigational product&#xD;
&#xD;
          9. Women of child bearing potential (WOCBP) who do not consent to using acceptable&#xD;
             methods of contraception (i.e. two of the following - oral contraception, barrier&#xD;
             contraception, intrauterine device). For purposes of this study, WOCBP include any&#xD;
             female who has experienced menarche, who has not undergone tubal ligation, and who is&#xD;
             not postmenopausal. Post menopause is defined as: amenorrhea ≥ 12 consecutive months&#xD;
             without another cause.&#xD;
&#xD;
         10. Women who are breast-feeding or have a positive pregnancy test at screening&#xD;
&#xD;
         11. Current participation in any other investigational clinical trial or any&#xD;
             administration of an investigational agent within 4 weeks of study drug administration&#xD;
             or 10 half-lives of the investigational agent, whichever is longer. Patients with&#xD;
             unresolved investigational treatment-related AEs may not participate.&#xD;
&#xD;
         12. Known or suspected hypersensitivity to AXL1717&#xD;
&#xD;
         13. Lack of suitability for participation in the trial, for any reason, as judged by the&#xD;
             Investigator&#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>Simon Ekman, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University Hospital, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KFUE</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 4, 2014</last_update_submitted>
  <last_update_submitted_qc>April 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2014</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>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Podophyllotoxin</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/NCT01725555
org study id: AXL010
nct id: NCT01725555
lead sponsor: 
has dmc: No
This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect
      of food on the bioavailability of AXL1717 including patients with advanced malignant tumors
This is a randomized, crossover, open label, phase I study to assess the effect of food on
      the bioavailability of AXL1717 in advanced cancer patients.

      A single, oral dose of AXL1717 is to be administered to patients on each of two occasions
      that are 7-day apart, in random order: after an overnight fast (fasted treatment) and with a
      high-fat or moderate-fat breakfast (fed treatment).
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient
time frame: several samples within 24 hours
measure: Safety of AXL1717 through adverse event reporting
time frame: Up to 30 days after last dose of study drug
arm group label: Fasted treatment
arm group type: Experimental
arm group label: Fed treatment
arm group type: Experimental
intervention type: Drug
intervention name: Fasted treatment: AXL1717
arm group label: Fasted treatment
arm group label: Fed treatment
intervention type: Drug
intervention name: Fed treatment: AXL1717
arm group label: Fasted treatment
arm group label: Fed treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Ekman, M.D., Ph.D.
role: Principal Investigator
affiliation: Uppsala University Hospital, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
mesh term: Podophyllotoxin