<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/NCT03030885</url>
  </required_header>
  <id_info>
    <org_study_id>16-1110</org_study_id>
    <nct_id>NCT03030885</nct_id>
  </id_info>
  <brief_title>Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)</brief_title>
  <official_title>A Phase 1, Open-Label, Dose Ascending Study to Evaluate the Safety and Tolerability of the Therapeutic Radiopharmaceutical 131I-MIP-1095 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Progenics Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study to determine the safety of an experimental medicine called&#xD;
      131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by&#xD;
      the U.S. Food &amp; Drug Administration (FDA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">April 2, 2019</completion_date>
  <primary_completion_date type="Actual">April 2, 2019</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>
    <intervention_model_description>This is a Phase 1, open-label, single-arm, dose ascending, out-patient study to evaluate the radiopharmaceutical 131I-MIP-1095 in men with mCRPC. The study consists of three phases: Screening, Treatment, and a Follow-up Phase. The Screening Phase consists of subject evaluation for study eligibility and dosimetry assessment. The Treatment Phase consists of two parts: Part 1, dose escalation (Cohorts 1-5), and Part 2, an additional cohort at a selected optimized dose based on safety and efficacy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD)</measure>
    <time_frame>2 years</time_frame>
    <description>This is a phase 1 dose escalation study of 131I-MIP-1095 in men with metastatic castration-resistant prostate cancer. There are a maximum of five doses under consideration. Dose escalation cohorts will be studied if acceptable toxicity is observed. A dose limiting toxicity is defined as the occurrence of any of the following drug-related toxicities during the first cycle.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Metastatic Castration-Resistant Prostate Cancer (mCRPC)</condition>
  <arm_group>
    <arm_group_label>131I-MIP-1095</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FirstTherapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose.&#xD;
2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>131I-MIP-1095</intervention_name>
    <description>First Therapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose.&#xD;
2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53</description>
    <arm_group_label>131I-MIP-1095</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males, age ≥18 years.&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed adenocarcinoma of the&#xD;
             prostate&#xD;
&#xD;
          -  Subjects must be castration resistant with evidence of progressive prostate cancer&#xD;
             despite castrate levels of testosterone (≤ 50 ng/dL) according to the PCWG3 criteria&#xD;
&#xD;
          -  Subjects must have metastatic disease detectable by either bone scan or cross&#xD;
             sectional imaging by CT or MRI as per the PCWG3 guidelines&#xD;
&#xD;
          -  Subjects must have progressive disease at study entry defined as 1 or more of the&#xD;
             following 3 criteria that occurred while the subject was on androgen deprivation&#xD;
             therapy:&#xD;
&#xD;
               -  PSA progression defined by a minimum of two rising PSA levels with an interval of&#xD;
                  ≥1 week between each determination. Subjects who received an anti-androgen as&#xD;
                  part of their primary hormonal therapy must demonstrate progression after&#xD;
                  withdrawal. The PSA value at screening should be ≥ 2 μg/L (2 ng/mL).&#xD;
&#xD;
               -  Soft tissue disease progression defined by RECIST 1.1&#xD;
&#xD;
               -  Bone disease progression defined by PCWG3 with two or more new lesions on bone&#xD;
                  scan.&#xD;
&#xD;
        Note: For subjects enrolling on the basis of soft tissue or bone progression, the baseline&#xD;
        scan must show progression relative to a comparison scan performed during prior therapy. If&#xD;
        the comparison scan is not available, the baseline scan report must reference the previous&#xD;
        scan to document progression&#xD;
&#xD;
          -  Subjects who received combined androgen blockade as their first-line hormonal therapy&#xD;
             with an antiandrogen must have shown PSA progression after discontinuing the&#xD;
             antiandrogen for ≥ 6 weeks prior to study treatment. No washout is needed after&#xD;
             abiraterone or enzalutamide are discontinued. First generation antiandrogens such as&#xD;
             bicalutamide must be withdrawn if given as first-line therapy.&#xD;
&#xD;
          -  ECOG Performance status of 0-1.&#xD;
&#xD;
          -  Adequate organ reserve as evidenced by:&#xD;
&#xD;
               1. neutrophil count ≥ 1500 μL&#xD;
&#xD;
               2. platelet count ≥ 100,000/μL&#xD;
&#xD;
               3. hemoglobin ≥ 9.5 g/dL&#xD;
&#xD;
               4. total bilirubin level ≤1.5 x ULN&#xD;
&#xD;
               5. AST and ALT ≤2.5 x ULN&#xD;
&#xD;
               6. serum amylase ≤ ULN&#xD;
&#xD;
               7. lipase ≤ ULN&#xD;
&#xD;
               8. serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min&#xD;
                  (Cockroft Gault equation)&#xD;
&#xD;
               9. clearance of 99mTc MAG3 within 1.5 x ULN and no evidence of obstruction on the&#xD;
                  scan.&#xD;
&#xD;
          -  Serum albumin of &gt; 3.0 g/dL&#xD;
&#xD;
          -  Subjects must have received, were ineligible to receive, or refused at least one&#xD;
             cytotoxic chemotherapy and enzalutamide or abiraterone or both enzalutamide and&#xD;
             abiraterone.&#xD;
&#xD;
          -  Subjects must agree to use a medically acceptable method of birth control (e.g.,&#xD;
             spermicide in conjunction with a barrier such as a condom) or sexual abstinence for&#xD;
             the duration of the study, including 30 days after the last dose of study drug. Sperm&#xD;
             donation is prohibited during the study and for 30 days after the last dose of study&#xD;
             drug. Female partners must use hormonal or barrier contraception unless postmenopausal&#xD;
             or abstinent.&#xD;
&#xD;
          -  Life expectancy ≥ 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has predominant histologically or cytologically confirmed neuroendocrine&#xD;
             prostate cancer (mixed histology is permissible, as is positivity of serum CgA and&#xD;
             CEA).&#xD;
&#xD;
          -  Subject has received an investigational therapeutic agent for prostate cancer within 4&#xD;
             weeks prior to the administration of 131I-MIP-1095.&#xD;
&#xD;
          -  Subject who has not recovered from the effects of any major surgery prior to initial&#xD;
             treatment&#xD;
&#xD;
          -  Subject has received treatment with a systemic therapeutic radioisotope (89Sr, 223Ra&#xD;
             dichloride, 153Sm-lexidronam) or has received prior external beam radiation therapy&#xD;
             (EBRT) of the head and/or neck.&#xD;
&#xD;
          -  Subject is currently on renal dialysis&#xD;
&#xD;
          -  Subject has started treatment with denosumab &lt; 1 month prior to study entry. Subjects&#xD;
             are allowed to be on bisphosphonates or denosumab provided they are on a stable dose&#xD;
             for ≥ 4 weeks before administration of study drug&#xD;
&#xD;
          -  Subject using chronic systemic steroids greater than the equivalent of 10 mg of&#xD;
             prednisone/prednisolone per day in the 2 weeks preceding study entry ; replacement&#xD;
             doses of steroids, topical, inhalational, nasal and ophthalmic steroids are permitted.&#xD;
&#xD;
          -  Diagnosis of other invasive malignancies within the preceding 3 years prior to&#xD;
             screening with &gt; 30% likelihood of relapse within the next 3 years, except&#xD;
             non-melanoma skin cancer and non-muscle invasive urothelial cancer&#xD;
&#xD;
          -  Any other serious illness or medical condition or social circumstance that might&#xD;
             interfere with the subject's participation in the trial or interfere with the&#xD;
             interpretation of the results, including, but not limited to:&#xD;
&#xD;
               1. any uncontrolled infection&#xD;
&#xD;
               2. NYHA Class III or Class IV heart failure&#xD;
&#xD;
               3. unstable angina&#xD;
&#xD;
               4. myocardial infarction within the 6 months prior to study entry&#xD;
&#xD;
               5. uncontrolled hypertension (systolic BP &gt; 160 mmHg despite 2 antihypertensive&#xD;
                  medications)&#xD;
&#xD;
               6. COPD requiring hospital admission in the year prior to study entry&#xD;
&#xD;
               7. diabetes mellitus requiring hospital admission in the year prior to study entry&#xD;
&#xD;
               8. chronic liver disease&#xD;
&#xD;
               9. hypothyroidism (TSH level &gt; 3.0 mIU/L)&#xD;
&#xD;
              10. substance abuse&#xD;
&#xD;
          -  Unable or unwilling to follow post-therapy radiation protection procedures&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Morris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiopharmaceutical (131I-MIP-1095)</keyword>
  <keyword>16-1110</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT03030885
org study id: 16-1110
nct id: NCT03030885
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study to determine the safety of an experimental medicine called
      131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by
      the U.S. Food & Drug Administration (FDA).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a Phase 1, open-label, single-arm, dose ascending, out-patient study to evaluate the radiopharmaceutical 131I-MIP-1095 in men with mCRPC. The study consists of three phases: Screening, Treatment, and a Follow-up Phase. The Screening Phase consists of subject evaluation for study eligibility and dosimetry assessment. The Treatment Phase consists of two parts: Part 1, dose escalation (Cohorts 1-5), and Part 2, an additional cohort at a selected optimized dose based on safety and efficacy.
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD)
time frame: 2 years
description: This is a phase 1 dose escalation study of 131I-MIP-1095 in men with metastatic castration-resistant prostate cancer. There are a maximum of five doses under consideration. Dose escalation cohorts will be studied if acceptable toxicity is observed. A dose limiting toxicity is defined as the occurrence of any of the following drug-related toxicities during the first cycle.
arm group label: 131I-MIP-1095
arm group type: Experimental
description: FirstTherapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose.
2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53
intervention type: Drug
intervention name: 131I-MIP-1095
description: First Therapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose.
2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53
arm group label: 131I-MIP-1095
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Morris, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Prostatic Neoplasms