<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/NCT01724320</url>
  </required_header>
  <id_info>
    <org_study_id>OTX008_101</org_study_id>
    <nct_id>NCT01724320</nct_id>
  </id_info>
  <brief_title>A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors</brief_title>
  <official_title>A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oncoethix GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oncoethix GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the recommended dose (RD) for further phase II&#xD;
      studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced&#xD;
      solid tumors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overexpression of galectin-1 protein is well documented in different types of cancers, with&#xD;
      associated bad prognostic and enhanced metastases spreading.&#xD;
&#xD;
      In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In&#xD;
      different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and&#xD;
      it was observed a blood vessels architecture normalization.&#xD;
&#xD;
      Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I&#xD;
      study aims to evaluate OTX008 therapy in patients with advanced solid tumors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <phase>Phase 1</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>Dose Limiting Toxicity</measure>
    <time_frame>up to 3 weeks of OTX008 treatment</time_frame>
    <description>Dose Limiting Toxicity (DLT) will be assessed during the first 21 days (3 weeks)of OTX008 treatment in each patient to determine Recommended Dose (RD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK)</measure>
    <time_frame>Days 1, 2 and 22 of OTX008 treatment</time_frame>
    <description>OTX008 plasma concentration will be assessed at days 1, 2 and 22 of OTX008 treatment to determine PK profile of OTX008. Following parameters will be used: Trough (Cmin) and peak (Cmax) of OTX008 concentrations, Tmax, t1/2, steady state, total clearance, AUC (Area Under Curve)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD)</measure>
    <time_frame>Days 1 and 22 of OTX008 treatment</time_frame>
    <description>Following parameter will be measured: plasma levels of galectin-1</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>OTX008</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTX008</intervention_name>
    <description>OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day</description>
    <arm_group_label>OTX008</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent prior to beginning protocol specific screening procedures.&#xD;
             Patients registered in this trial must be treated and followed at the participating&#xD;
             centers. Patients should receive the study treatment within 7 days after registration&#xD;
&#xD;
          -  Histologically proven malignant solid tumor&#xD;
&#xD;
          -  Patients having failed all standard therapies, or for whom standard therapies are&#xD;
             deemed ineffective or contra-indicated.&#xD;
&#xD;
          -  Patients aged &gt; 18 years.&#xD;
&#xD;
          -  ECOG performance status (PS) of 0 to 1&#xD;
&#xD;
          -  Off previous systemic therapy (except LH-RH agonist therapy started &gt; 2 months prior&#xD;
             to study entry that could be continued) , radiation therapy, or surgery for at least&#xD;
             30 days prior to first study treatment administration (45 days for bicalutamide).&#xD;
&#xD;
          -  Recovery from the toxic effects of prior treatment to NCIC-CTC grade &lt; 1, except&#xD;
             alopecia&#xD;
&#xD;
          -  Adequate bone marrow function including: Neutrophils &gt;= 1.5 x 10E9 /L; platelets &gt;=&#xD;
             100 x 10E9 /L, Hb &gt; 8g/dL without transfusion.&#xD;
&#xD;
          -  Creatinine clearance &gt;= 60 mL/min (Cockroft &amp; Gault formula, or MDRD formula for&#xD;
             patients aged &gt; 65 years).&#xD;
&#xD;
          -  Adequate LFTs: Total bilirubin &lt; 1 x the institutional upper normal limits (UNL);&#xD;
             ALAT/ASAT &gt;= 3 x UNL (or &gt;= 5 x UNL in case of liver metastases).&#xD;
&#xD;
          -  Serum albumin &gt; 28g/L.&#xD;
&#xD;
          -  Availability of the last tumor imaging within 6 months prior to baseline tumor imaging&#xD;
&#xD;
          -  Availability of archived pathology specimen (paraffin-embedded block) from the tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior malignancy other than those previously treated with a curative intent&#xD;
             more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in&#xD;
             situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps&#xD;
             treated adequately, regardless of the disease-free interval.&#xD;
&#xD;
          -  Pregnant or lactating women or women of childbearing potential not using adequate&#xD;
             contraception. Male patients not using adequate contraception.&#xD;
&#xD;
          -  Tumor sites that necessitate immediate intervention (supportive care, surgery or&#xD;
             radiation therapy) such as symptomatic brain or leptomeningeal tumor, spinal cord&#xD;
             compression, other compressive tumor masses, painful bone metastasis, bone fracture,&#xD;
             etc…&#xD;
&#xD;
          -  Other serious illness or medical conditions, which, in the investigator's opinion&#xD;
             could jeopardize patient's safety or hamper understanding of the study by the patient,&#xD;
             patient's compliance to study treatment, or interpretation of study results. These&#xD;
             conditions include (but are not restricted to):&#xD;
&#xD;
               1. Congestive heart failure or angina pectoris not medically controlled. Previous&#xD;
                  history of myocardial infarction within 1 year from study entry, uncontrolled&#xD;
                  hypertension or arrhythmias.&#xD;
&#xD;
               2. Existence of significant neurologic or psychiatric disorders impairing the&#xD;
                  ability to obtain consent.&#xD;
&#xD;
               3. Active infection.&#xD;
&#xD;
          -  Concurrent treatment with other experimental therapies or participation in another&#xD;
             clinical trial within 30 days prior to first study treatment administration.&#xD;
&#xD;
          -  Concurrent treatment with any other anticancer therapy (except LH-RH agonist therapy&#xD;
             initiated &gt; 2 months prior to study entry).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patrice HERAIT, MD</last_name>
    <phone>+33 6 85 12</phone>
    <phone_ext>00 18</phone_ext>
    <email>pherait@phconsult-onco.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad AWADA, MD</last_name>
      <phone>+32 2 541</phone>
      <phone_ext>31 89</phone_ext>
      <email>ahmad.awada@bordet.be</email>
    </contact>
    <investigator>
      <last_name>Ahmad AWADA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon - AP-HP</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric RAYMOND, MD</last_name>
      <phone>+33 1 40 87</phone>
      <phone_ext>56 17</phone_ext>
      <email>eric.raymond@bjn.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Eric RAYMOND, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Pierre DELORD, MD</last_name>
      <phone>+33 5 67 22</phone>
      <phone_ext>25 67</phone_ext>
      <email>delord.jean-pierre@claudiusregaud.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Pierre DELORD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>solid tumors</keyword>
  <keyword>first-in-man</keyword>
  <keyword>phase I</keyword>
  <keyword>cancer</keyword>
  <keyword>galectin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_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/NCT01724320
org study id: OTX008_101
nct id: NCT01724320
lead sponsor: 
has dmc: No
The purpose of this study is to determine the recommended dose (RD) for further phase II
      studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced
      solid tumors
Overexpression of galectin-1 protein is well documented in different types of cancers, with
      associated bad prognostic and enhanced metastases spreading.

      In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In
      different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and
      it was observed a blood vessels architecture normalization.

      Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I
      study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Limiting Toxicity
time frame: up to 3 weeks of OTX008 treatment
description: Dose Limiting Toxicity (DLT) will be assessed during the first 21 days (3 weeks)of OTX008 treatment in each patient to determine Recommended Dose (RD)
measure: Pharmacokinetics (PK)
time frame: Days 1, 2 and 22 of OTX008 treatment
description: OTX008 plasma concentration will be assessed at days 1, 2 and 22 of OTX008 treatment to determine PK profile of OTX008. Following parameters will be used: Trough (Cmin) and peak (Cmax) of OTX008 concentrations, Tmax, t1/2, steady state, total clearance, AUC (Area Under Curve)
measure: Pharmacodynamics (PD)
time frame: Days 1 and 22 of OTX008 treatment
description: Following parameter will be measured: plasma levels of galectin-1
arm group label: OTX008
arm group type: Experimental
description: Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day.
intervention type: Drug
intervention name: OTX008
description: OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day
arm group label: OTX008
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrice HERAIT, MD
phone: +33 6 85 12
phone ext: 00 18
email: pherait@phconsult-onco.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
country: France
responsible party type: Sponsor
mesh term: Neoplasms