<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/NCT01701349</url>
  </required_header>
  <id_info>
    <org_study_id>OX4317s</org_study_id>
    <nct_id>NCT01701349</nct_id>
  </id_info>
  <brief_title>Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer</brief_title>
  <acronym>FACT2</acronym>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Fosbretabulin Tromethamine (CA4P) in Combination With Paclitaxel and Carboplatin in Anaplastic Thyroid Carcinoma (FACT2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mateon Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mateon Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin&#xD;
      given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with&#xD;
      chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC).&#xD;
      The primary objective of the study is to determine overall survival. A maximum of 300&#xD;
      subjects will be recruited from approximately 75 multinational sites of which approximately&#xD;
      35 will be located in the United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Treatment Plan followed for all subjects will consist of:&#xD;
&#xD;
        -  A Screening Visit within 14 days before study drug (fosbretabulin or placebo)&#xD;
           administration&#xD;
&#xD;
        -  A Treatment Phase of 21-day combination treatment (study drug plus chemotherapy) cycles&#xD;
           (up to 6 cycles)&#xD;
&#xD;
        -  An End of Treatment Phase assessment&#xD;
&#xD;
        -  An End of Study Visit occurring 30 days after the last day of study drug administration,&#xD;
           as able&#xD;
&#xD;
      After the last clinic visit, all subjects will be followed for survival by monthly phone&#xD;
      calls, email, or in-person.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Expected inability to recruit study participants in a reasonable amount of time.&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Maximun length of study for each subject is 2 years from date of randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin</measure>
    <time_frame>Maximun length of study for each subject is 2 years from date of randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with 1-year survival</measure>
    <time_frame>Maximun length of study for each subject is 2 years from date of randomization</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Determine the proportion of subjects with measurable disease who have objective tumor response, by treatment</measure>
    <time_frame>Maximun length of study for each subject is 2 years from date of randomization</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anaplastic Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Fosbretabulin + paclitaxel + carboplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Six 21 day cycles of:&#xD;
Fosbretabulin (60 mg/m2) IV on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC 6) IV on Day 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + paclitaxel + carboplatin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Six 21-day cycles of:&#xD;
Placebo (formulated and packages to match fosbretabulin)on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC6) IV on Day 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fosbretabulin + paclitaxel + carboplatin</intervention_name>
    <description>Fosbretabulin 200 mg/m2 IV infusion</description>
    <arm_group_label>Fosbretabulin + paclitaxel + carboplatin</arm_group_label>
    <other_name>Fosbretabulin</other_name>
    <other_name>Combretastatin</other_name>
    <other_name>Zybrestat</other_name>
    <other_name>CA4P</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo + paclitaxel + carboplatin</intervention_name>
    <description>Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion</description>
    <arm_group_label>Placebo + paclitaxel + carboplatin</arm_group_label>
    <other_name>Paclitaxel</other_name>
    <other_name>Carboplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unresectable, residual, recurrent or persistent ATC, histologically or cytologically&#xD;
             confirmed&#xD;
&#xD;
          -  Prior cytotoxic therapeutic regimen as primary therapy for curative intent or prior&#xD;
             targeted therapies (TKIs) are eligible (Prior taxane or platinum therapy is allowed)&#xD;
&#xD;
          -  Untreated ATC following biopsy, surgery for curative intent, palliation, or after&#xD;
             radiation therapy has been considered or administered with or without radiosensitizing&#xD;
             chemotherapy&#xD;
&#xD;
          -  Disease present on clinical exam (measurable or non-measurable)&#xD;
&#xD;
          -  Distant metastases (Stage IVC) only must have histologic confirmation of ATC either&#xD;
             from the original primary lesion or a metastatic site&#xD;
&#xD;
          -  Neoadjuvant therapy with radiation and either radiosensitizing chemotherapy followed&#xD;
             by surgery for curative intent, palliation, or biopsy are eligible if residual or&#xD;
             persistent ATC is present&#xD;
&#xD;
          -  Subjects with tracheostomy are eligible&#xD;
&#xD;
          -  ECOG PS 2 or less&#xD;
&#xD;
          -  Adequate bone marrow, renal, and hepatic function, electrolytes WNL for the&#xD;
             institution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease that is able to be completely resected with negative microscopic margins and&#xD;
             without any residual disease in the body&#xD;
&#xD;
          -  Active brain metastases, including symptomatic involvement, evidence of cerebral edema&#xD;
             by prior CT or MRI, radiographic evidence of brain metastasis since definitive&#xD;
             therapy, or continued requirement for corticosteroids for cerebral edema&#xD;
&#xD;
          -  History of malignancies other than ACT except prior lower grade thyroid malignancy,&#xD;
             curatively treated basal cell carcinoma and in-situ melanoma of the skin, cervical&#xD;
             intra-epithelial neoplasia,localized prostate cancer, in-situ carcinoma of the breast&#xD;
&#xD;
          -  Known intolerance or hypersensitivity to fosbretabulin, paclitaxel, carboplatin or any&#xD;
             of their components&#xD;
&#xD;
          -  Receiving concurrent investigational therapy or have received investigational therapy&#xD;
             for any indication within 28 days of the first scheduled day of dosing&#xD;
&#xD;
          -  Grade 3 or greater peripheral neuropathy&#xD;
&#xD;
          -  History of prior cerebrovascular event,including transient ischemic attack within the&#xD;
             past 6 months&#xD;
&#xD;
          -  Uncontrolled hypertension defined as blood pressure &gt;150/100 mm Hg despite medication&#xD;
&#xD;
          -  Symptomatic vascular disease (e.g. intermittent claudication)&#xD;
&#xD;
          -  History of unstable angina pectoris pattern, myocardial infarction (including non-Q&#xD;
             wave) within the past 6 months, or NYHA Class III or IV congestive heart failure&#xD;
&#xD;
          -  History of torsade de pointes, ventricular tachycardia, ventricular fibrillation or&#xD;
             congenital long QT syndrome.&#xD;
&#xD;
          -  Pathologic bradycardia (&lt;60 b/m or heart block(excluding 1st degree block, consisting&#xD;
             of PR interval prolongation only)&#xD;
&#xD;
          -  ECG findings of clinically significant ventricular arrhythmia, new ST segment&#xD;
             elevation or depression, or new Q wave on ECG (PVCs are not excluded).&#xD;
&#xD;
          -  QTc interval 480 ms or more&#xD;
&#xD;
          -  Requirement of concurrent treatment with any drugs know to prolong the QTc interval,&#xD;
             including anti-arrhythmic medications&#xD;
&#xD;
          -  Potassium and/or magnesium concentrations below normal range for the reference&#xD;
             laboratory&#xD;
&#xD;
          -  History of solid organ or bone marrow transplant&#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>Marcia Brose, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania, Philadelphia, PA 19104</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie A Sosa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University, New Haven, CT 06520</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Licitra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy</affiliation>
  </overall_official>
  <link>
    <url>http://thyca.org</url>
    <description>Thyroid Cancer Survivors' Association, Inc.</description>
  </link>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>April 30, 2014</last_update_submitted>
  <last_update_submitted_qc>April 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ATC</keyword>
  <keyword>Anaplastic Thyroid Cancer</keyword>
  <keyword>Stage IVC Anaplastic Thyroid Cancer</keyword>
  <keyword>Thyroid Cancer</keyword>
  <keyword>Head and Neck Tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Carcinoma, Anaplastic</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Fosbretabulin</mesh_term>
    <mesh_term>Combretastatin</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</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/NCT01701349
org study id: OX4317s
nct id: NCT01701349
lead sponsor: 
has dmc: Yes
This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin
      given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with
      chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC).
      The primary objective of the study is to determine overall survival. A maximum of 300
      subjects will be recruited from approximately 75 multinational sites of which approximately
      35 will be located in the United States.
The Treatment Plan followed for all subjects will consist of:

        -  A Screening Visit within 14 days before study drug (fosbretabulin or placebo)
           administration

        -  A Treatment Phase of 21-day combination treatment (study drug plus chemotherapy) cycles
           (up to 6 cycles)

        -  An End of Treatment Phase assessment

        -  An End of Study Visit occurring 30 days after the last day of study drug administration,
           as able

      After the last clinic visit, all subjects will be followed for survival by monthly phone
      calls, email, or in-person.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall survival
time frame: Maximun length of study for each subject is 2 years from date of randomization
measure: Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin
time frame: Maximun length of study for each subject is 2 years from date of randomization
measure: Number of participants with 1-year survival
time frame: Maximun length of study for each subject is 2 years from date of randomization
measure: Determine the proportion of subjects with measurable disease who have objective tumor response, by treatment
time frame: Maximun length of study for each subject is 2 years from date of randomization
arm group label: Fosbretabulin + paclitaxel + carboplatin
arm group type: Active Comparator
description: Six 21 day cycles of:
Fosbretabulin (60 mg/m2) IV on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC 6) IV on Day 2
arm group label: Placebo + paclitaxel + carboplatin
arm group type: Placebo Comparator
description: Six 21-day cycles of:
Placebo (formulated and packages to match fosbretabulin)on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC6) IV on Day 2
intervention type: Drug
intervention name: Fosbretabulin + paclitaxel + carboplatin
description: Fosbretabulin 200 mg/m2 IV infusion
arm group label: Fosbretabulin + paclitaxel + carboplatin
other name: Fosbretabulin
other name: Combretastatin
other name: Zybrestat
other name: CA4P
intervention type: Drug
intervention name: Placebo + paclitaxel + carboplatin
description: Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion
arm group label: Placebo + paclitaxel + carboplatin
other name: Paclitaxel
other name: Carboplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcia Brose, MD, PhD
role: Principal Investigator
affiliation: University of Pennsylvania, Philadelphia, PA 19104
last name: Julie A Sosa, MD
role: Principal Investigator
affiliation: Yale University, New Haven, CT 06520
last name: Lisa Licitra, MD
role: Principal Investigator
affiliation: Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy
url: http://thyca.org
description: Thyroid Cancer Survivors' Association, Inc.
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Carcinoma, Anaplastic
mesh term: Thyroid Diseases
mesh term: Paclitaxel
mesh term: Fosbretabulin
mesh term: Combretastatin
mesh term: Albumin-Bound Paclitaxel
mesh term: Carboplatin