<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/NCT01665183</url>
  </required_header>
  <id_info>
    <org_study_id>POLARIS2012-005</org_study_id>
    <nct_id>NCT01665183</nct_id>
  </id_info>
  <brief_title>Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma</brief_title>
  <official_title>Phase 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Advanced Solid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polaris Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polaris Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from&#xD;
      microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has&#xD;
      been used to treat patients that have cancers that require arginine. In this study, ADI will&#xD;
      be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy&#xD;
      of this combination will be explored in patients with cancers that require arginine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Number of participants with adverse events.</measure>
    <time_frame>Course of study.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with objective responses.</measure>
    <time_frame>Course of study.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>ADI-PEG 20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>arginine deiminase formulated with polyethylene glycol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADI-PEG 20</intervention_name>
    <arm_group_label>ADI-PEG 20</arm_group_label>
    <other_name>arginine deiminase formulated with polyethylene glycol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed diagnosis of advanced solid tumor (dose escalation component)&#xD;
             or metastatic melanoma (uveal or cutaneous) (doses escalation and MTD expansion&#xD;
             components) or platinum-resistant (tumor progression within a year after the&#xD;
             completion of platinum-based therapy) ovarian carcinoma (high grade serous,&#xD;
             endometrial or poorly differentiated endometrioid) or HCC that has failed treatment&#xD;
             with sorafenib or did not tolerate sorafenib or refused sorafenib, or HCC with&#xD;
             coexistent BCT that has or has not been treated with chemotherapy, or BCT that has or&#xD;
             has not been treated with chemotherapy. For HCC and HCC with coexistent BCT, cirrhotic&#xD;
             status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be&#xD;
             determined based on clinical findings and laboratory data during the screening period&#xD;
             (Appendix C). Subjects on anti-coagulants are to receive 1 point for their INR status,&#xD;
             as they are presumed to have a &lt;1.7 baseline PT/INR.&#xD;
&#xD;
          2. Ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only tissue either from an&#xD;
             archived specimen or from a new biopsy of sufficient amount and quality should be&#xD;
             available for IHC determination of ASS status to be performed retrospectively for the&#xD;
             ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only cohorts. Subjects with&#xD;
             no tissue available would require a biopsy.&#xD;
&#xD;
          3. Unresectable disease or patient refused surgery.&#xD;
&#xD;
          4. Progressive disease if treated with chemotherapy, radiotherapy, surgery or&#xD;
             immunotherapy. If prior radiation was given, the measurable disease should be outside&#xD;
             the radiation port. Unequivocal progression of HCC/BTC lesions previously treated with&#xD;
             catheter-based therapy including transarterial chemoembolization or radioembolization&#xD;
             is allowed.&#xD;
&#xD;
          5. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).&#xD;
&#xD;
          6. Age ≥ 18 years.&#xD;
&#xD;
          7. ECOG performance status of 0 - 1.&#xD;
&#xD;
          8. No prior systemic therapy, immunotherapy, investigational agent, chemoembolization,&#xD;
             radioembolization or radiation therapy within the last 4 weeks.&#xD;
&#xD;
          9. Fully recovered from any prior surgery and no major surgery within 4 weeks of&#xD;
             initiating treatment, except for gamma knife which can take place within 2 weeks.&#xD;
             Surgery for placement of vascular access devices is acceptable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious infection requiring treatment with systemically administered antibiotics at&#xD;
             the time of study entrance, or an infection requiring systemic antibiotic therapy&#xD;
             within 7 days prior to the first dose of study treatment. For the HCC, HCC/BTC and BTC&#xD;
             subgroups hepatitis C infection and hepatitis B infection if controlled with antiviral&#xD;
             therapy are allowable.&#xD;
&#xD;
          2. Pregnancy or lactation.&#xD;
&#xD;
          3. Expected non-compliance.&#xD;
&#xD;
          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure (New York Heart Association Class III&#xD;
             or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit&#xD;
             compliance with study requirements.&#xD;
&#xD;
          5. Subjects who have had any anticancer treatment prior to entering the study and have&#xD;
             not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible&#xD;
             from the effects of prior cancer therapy. AEs &gt; Grade 1 that are not considered a&#xD;
             safety risk by the Sponsor and investigator may be allowed upon agreement with both.&#xD;
&#xD;
          6. Subjects with history of another primary cancer, including co-existent second&#xD;
             malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b)&#xD;
             curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no&#xD;
             known active disease present in the opinion of the investigator will not affect&#xD;
             patient outcome in the setting of current cancer diagnosis.&#xD;
&#xD;
          7. Subjects who had been treated with ADI-PEG 20 previously.&#xD;
&#xD;
          8. History of seizure disorder not related to underlying cancer.&#xD;
&#xD;
          9. Known HIV positivity (testing not required).&#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>Siqing Fu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NCKUH</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>February 24, 2016</last_update_submitted>
  <last_update_submitted_qc>February 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>argininosuccinate synthetase</keyword>
  <keyword>arginine</keyword>
  <keyword>arginine deiminase</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</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/NCT01665183
org study id: POLARIS2012-005
nct id: NCT01665183
lead sponsor: 
has dmc: No
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from
      microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has
      been used to treat patients that have cancers that require arginine. In this study, ADI will
      be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy
      of this combination will be explored in patients with cancers that require arginine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events.
time frame: Course of study.
measure: Number of participants with objective responses.
time frame: Course of study.
arm group label: ADI-PEG 20
arm group type: Experimental
description: arginine deiminase formulated with polyethylene glycol
intervention type: Drug
intervention name: ADI-PEG 20
arm group label: ADI-PEG 20
other name: arginine deiminase formulated with polyethylene glycol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Siqing Fu, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
facility: 
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Melanoma