<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/NCT04492436</url>
  </required_header>
  <id_info>
    <org_study_id>3-2001B</org_study_id>
    <nct_id>NCT04492436</nct_id>
  </id_info>
  <brief_title>A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Veloxis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Veloxis Pharmaceuticals</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>
      To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced&#xD;
      peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who&#xD;
      receive oxaliplatin-containing chemotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory&#xD;
      symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable&#xD;
      metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study design was changed&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2021</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2023</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FACT/GOG-NTX-12 (4 items) Total Score at 9 Months</measure>
    <time_frame>9 months</time_frame>
    <description>Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Proportion of subjects scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Cumulative incidence of scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 through Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS (Pain) Scores (feet) at Cycle 9</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline score of NRS (Pain) in feet at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS (Pain) Scores (hands) at Cycle 9</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline score of NRS (Pain) in hands at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effect Questionnaire Score</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline score of Side effect questionnaire at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CTCAE: Peripheral Sensory Neuropathy</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CTCAE: Peripheral Motor Neuropathy</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mTCNS Score</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline in total score of mTCNS at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grooved Pegboard Change</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L Change</measure>
    <time_frame>Cycle 9 (each cycle is 2 weeks)</time_frame>
    <description>Change from baseline in EQ-5D-5L index value at the end of Cycle 9</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>thrombomodulin alfa</intervention_name>
    <description>Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle</description>
    <arm_group_label>High Dose</arm_group_label>
    <arm_group_label>Low Dose</arm_group_label>
    <other_name>ART-123</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Unresectable metastatic colorectal cancer; pathologically confirmed adenocarcinoma of&#xD;
             the colon or rectum&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  The most recent laboratory findings (including for liver and kidney) within 14 days&#xD;
             prior to randomization remain within acceptable ranges&#xD;
&#xD;
          -  Willingness of the patient and the sexual partner to use a highly effective&#xD;
             contraceptive method during the course of the study&#xD;
&#xD;
          -  Able to sufficiently understand the clinical study and give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment history with nerve toxic chemotherapeutic agent&#xD;
&#xD;
          -  Peripheral neuropathy or central nervous system damage&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  History of major hemorrhage&#xD;
&#xD;
          -  High risk of hemorrhage&#xD;
&#xD;
          -  History of other malignancies&#xD;
&#xD;
          -  Active ulcer&#xD;
&#xD;
          -  Patients using anti-coagulants and fibrinolytic drugs&#xD;
&#xD;
          -  Active Hepatitis B, or known HBs antigen positive&#xD;
&#xD;
          -  Prior treatment history with thrombomodulin alfa&#xD;
&#xD;
          -  Administration of another investigational medicinal product within 30 days prior to&#xD;
             randomization&#xD;
&#xD;
          -  Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or&#xD;
             intends to get pregnant during the Treatment period&#xD;
&#xD;
          -  Patients otherwise deemed as inappropriate to participate in the study 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>David Fineberg, MD</last_name>
    <role>Study Director</role>
    <affiliation>Veloxis Pharmaceuticals</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 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>Peripheral Nervous System Diseases</mesh_term>
  </condition_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/NCT04492436
org study id: 3-2001B
nct id: NCT04492436
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced
      peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who
      receive oxaliplatin-containing chemotherapy
To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory
      symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable
      metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
measure: FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
time frame: 9 months
description: Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months
measure: FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)
time frame: Cycle 9 (each cycle is 2 weeks)
description: Proportion of subjects scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
measure: FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
time frame: Cycle 9 (each cycle is 2 weeks)
description: Cumulative incidence of scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 through Cycle 9
measure: FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9
measure: NRS (Pain) Scores (feet) at Cycle 9
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline score of NRS (Pain) in feet at the end of Cycle 9
measure: NRS (Pain) Scores (hands) at Cycle 9
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline score of NRS (Pain) in hands at the end of Cycle 9
measure: Side Effect Questionnaire Score
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline score of Side effect questionnaire at the end of Cycle 9
measure: CTCAE: Peripheral Sensory Neuropathy
time frame: Cycle 9 (each cycle is 2 weeks)
description: Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9
measure: CTCAE: Peripheral Motor Neuropathy
time frame: Cycle 9 (each cycle is 2 weeks)
description: Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9
measure: mTCNS Score
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline in total score of mTCNS at the end of Cycle 9
measure: Grooved Pegboard Change
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9
measure: EQ-5D-5L Change
time frame: Cycle 9 (each cycle is 2 weeks)
description: Change from baseline in EQ-5D-5L index value at the end of Cycle 9
arm group label: Low Dose
arm group type: Experimental
description: Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
arm group label: High Dose
arm group type: Experimental
description: Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
arm group label: Placebo
arm group type: Placebo Comparator
description: Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
intervention type: Drug
intervention name: thrombomodulin alfa
description: Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
arm group label: High Dose
arm group label: Low Dose
other name: ART-123
intervention type: Drug
intervention name: Placebo
description: Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Fineberg, MD
role: Study Director
affiliation: Veloxis Pharmaceuticals
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No