<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/NCT03005262</url>
  </required_header>
  <id_info>
    <org_study_id>CTMS 16-0122</org_study_id>
    <nct_id>NCT03005262</nct_id>
  </id_info>
  <brief_title>MLN8237 for a Subject With Adenocarcinoma of the Prostate</brief_title>
  <official_title>Expanded Access To MLN8237, For An Individual Patient With Adenocarcinoma Of The Prostate (CTMS# 16-0122)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <brief_summary>
    <textblock>
      To allow a patient continued access to MLN8237&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate&#xD;
    </textblock>
  </detailed_description>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLN8237</intervention_name>
    <other_name>Alisertib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Histologically or cytologically confirmed advanced tumors and candidates for docetaxel&#xD;
             treatment&#xD;
&#xD;
          -  Measurable or evaluable disease is required. Patients must have clinical evidence of&#xD;
             progressive disease or persistent disease&#xD;
&#xD;
          -  Patients with castration-resistant prostate cancer (CRPC) are required to have&#xD;
&#xD;
          -  Pathologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Evidence of metastatic disease on bone scan or other imaging. Patients with PSA&#xD;
             elevation as the only manifestation of disease are not eligible.&#xD;
&#xD;
          -  Progressive disease after at least 1 hormonal treatment with documented testosterone&#xD;
             levels less than 50 ng/dl&#xD;
&#xD;
          -  Concurrent use of an agent for testosterone suppression (e.g., LHRH agonist) is&#xD;
             required if the patient has not been surgically castrated&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Recovered to less than or equal to Grade 1 toxicity (CTCAE), to patient's baseline&#xD;
             status (except alopecia) or deemed irreversible from the effects of prior cancer&#xD;
             therapy and must have evidence of progressive or persistent disease&#xD;
&#xD;
          -  Adequate bone marrow, liver and renal function&#xD;
&#xD;
          -  Any use of opiates must be stable for at least 2 weeks prior to study entry&#xD;
&#xD;
          -  Male patients who agree to practice effective barrier contraception during the entire&#xD;
             study and through 6 months after the last dose of study drug OR agree to abstain from&#xD;
             heterosexual intercourse&#xD;
&#xD;
          -  Voluntary written consent&#xD;
&#xD;
          -  Willing to comply with scheduled visits, treatment plan, laboratory tests and other&#xD;
             trial procedures&#xD;
&#xD;
          -  Suitable venous access for blood sampling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antineoplastic therapy or any experimental therapy within 21 days before the first&#xD;
             dose of MLN8237&#xD;
&#xD;
          -  Prior or current investigational therapies within 4 weeks before the first dose of&#xD;
             MLN8237&#xD;
&#xD;
          -  Radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized,&#xD;
             small field radiation) within 4 weeks prior to enrollment, unless reviewed and&#xD;
             approved by the medical monitor&#xD;
&#xD;
          -  Nitrosoureas or mitomycin-C within 6 weeks before the first dose of MLN8237.&#xD;
&#xD;
          -  Autologous stem cell transplant within 3 months before the first dose of MLN8237, or&#xD;
             prior allogeneic stem cell transplant at any time.&#xD;
&#xD;
          -  Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or&#xD;
             phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days&#xD;
             prior to the first dose of MLN8237&#xD;
&#xD;
          -  For CRPC patients:&#xD;
&#xD;
          -  Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Prior treatment with antineoplastic chemotherapy or radioisotopes for advanced&#xD;
             prostate cancer&#xD;
&#xD;
          -  Use of products known to affect PSA levels within 4 weeks of enrollment&#xD;
&#xD;
          -  Major surgery within 4 weeks of study enrollment&#xD;
&#xD;
          -  Uncontrolled high blood pressure&#xD;
&#xD;
          -  Patients with abnormal gastric or bowel function or who require continuous treatment&#xD;
             with antacids or proton pump inhibitors&#xD;
&#xD;
          -  Patients receiving chronic steroid therapy other than the following: low dose steroid&#xD;
             for the control of nausea and vomiting, topical steroid, inhaled steroid or use of&#xD;
             dexamethasone&#xD;
&#xD;
          -  Known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80&#xD;
&#xD;
          -  Comorbid condition or unresolved toxicity that would preclude administration of&#xD;
             docetaxel&#xD;
&#xD;
          -  Prior history of Grade 2 or greater neurotoxicity or any toxicity that has not&#xD;
             resolved to Grade 1 or below&#xD;
&#xD;
          -  Symptomatic brain or other CNS metastasis&#xD;
&#xD;
          -  Diagnosis or treatment of another malignancy within 2 years preceding first dose of&#xD;
             study drug except nonmelanoma skin cancer or in situ malignancy completely resected&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or&#xD;
             hepatitis C&#xD;
&#xD;
          -  Patients requiring full systemic anticoagulation&#xD;
&#xD;
          -  Prior allogeneic bone marrow or other organ transplant&#xD;
&#xD;
          -  Active infection requiring systemic therapy within 14 days preceding first dose, or&#xD;
             other serious infection&#xD;
&#xD;
          -  History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months&#xD;
&#xD;
          -  Serious medical or psychiatric illness that could interfere with protocol completion&#xD;
&#xD;
          -  Inability to swallow oral medication&#xD;
&#xD;
          -  Prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens&#xD;
&#xD;
          -  Prior treatment with more than 1 prior taxane-containing regimen&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>April 2, 2018</last_update_submitted>
  <last_update_submitted_qc>April 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</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>Adenocarcinoma</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/NCT03005262
org study id: CTMS 16-0122
nct id: NCT03005262
lead sponsor: 
To allow a patient continued access to MLN8237
Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate
intervention type: Drug
intervention name: MLN8237
other name: Alisertib
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 100 Years
responsible party type: Sponsor
mesh term: Adenocarcinoma