<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/NCT01689220</url>
  </required_header>
  <id_info>
    <org_study_id>SP-02L03</org_study_id>
    <nct_id>NCT01689220</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea</brief_title>
  <official_title>A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Solasia Pharma K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Synex Consulting Korea Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Solasia Pharma K.K.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in&#xD;
      Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Incidence of dose-limiting toxicity and adverse events</measure>
    <time_frame>12 or 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response (overall response)</measure>
    <time_frame>2 and 4 cycles</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration-time profile</measure>
    <time_frame>0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15</time_frame>
    <description>Cmax, Area under curve, Tmax, t1/2, Clearance and Volume of distribution</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Peripheral T-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>SP-02L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SP-02L (darinaparsin for injection)</intervention_name>
    <description>Cohort 1: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.</description>
    <arm_group_label>SP-02L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SP-02L (darinaparsin for injection)</intervention_name>
    <description>Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.</description>
    <arm_group_label>SP-02L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent&#xD;
&#xD;
          -  Patients with histologically confirmed diagnosis of the following:&#xD;
&#xD;
               -  PTCL, not otherwise specified (PTCL-NOS)&#xD;
&#xD;
               -  Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)&#xD;
&#xD;
               -  Angioimmunoblastic T-cell Lymphoma (AITL)&#xD;
&#xD;
          -  Have relapsed or refractory to at least one prior systemic chemotherapy for the above&#xD;
             disease (currently requiring therapy)&#xD;
&#xD;
          -  Have at least 1 evaluable lesion&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</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/NCT01689220
org study id: SP-02L03
nct id: NCT01689220
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in
      Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of dose-limiting toxicity and adverse events
time frame: 12 or 16 weeks
measure: Tumor response (overall response)
time frame: 2 and 4 cycles
measure: Plasma concentration-time profile
time frame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15
description: Cmax, Area under curve, Tmax, t1/2, Clearance and Volume of distribution
arm group label: SP-02L
arm group type: Experimental
intervention type: Drug
intervention name: SP-02L (darinaparsin for injection)
description: Cohort 1: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
arm group label: SP-02L
intervention type: Drug
intervention name: SP-02L (darinaparsin for injection)
description: Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
arm group label: SP-02L
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral