<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/NCT04494113</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2020-05457</org_study_id>
    <secondary_id>NCI-2020-05457</secondary_id>
    <secondary_id>10401</secondary_id>
    <secondary_id>10401</secondary_id>
    <secondary_id>UM1CA186691</secondary_id>
    <nct_id>NCT04494113</nct_id>
  </id_info>
  <brief_title>Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the Tissue at the Time of Hysterectomy</brief_title>
  <official_title>A Phase 0 Window-of-Opportunity Pharmacodynamic Trial of Triapine (NSC# 663249) in Uterine Corpus Serous Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This early phase I trial investigates the response to the anti-cancer drug, triapine, in&#xD;
      uterine cancers by using markers from tissue samples at the time of removal of the uterus,&#xD;
      ovaries, and fallopian tubes (hysterectomy and bilateral salpingo-oophorectomy). Triapine may&#xD;
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding&#xD;
      triapine to the usual approach of surgery followed by chemotherapy alone or in combination&#xD;
      with radiation therapy may help to slow the growth of uterine cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Determine whether intravenous (IV) triapine 25 mg/m^2 will induce cell cycle arrest as&#xD;
      measured by phospho-histone H3 (pHH3) in uterine serous adenocarcinoma cells removed at the&#xD;
      time of hysterectomy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Determine whether a preoperative dose of intravenous triapine 25 mg/m^2 can be safely&#xD;
      given prior to hysterectomy and staging for uterine serous adenocarcinoma.&#xD;
&#xD;
      II. Determine whether changes in cyclin D/E and Ki-67 protein expression are detectable using&#xD;
      immunohistochemistry pre- and post-triapine treatment in uterine serous adenocarcinomas.&#xD;
&#xD;
      III. Evaluate plasma and tissue triapine concentrations.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. Determine the feasibility of using single-cell transcriptome analysis to quantify changes&#xD;
      in gene expression following triapine treatment and to evaluate their concordance with&#xD;
      immunohistochemistry (IHC) endpoints of cell cycle arrest.&#xD;
&#xD;
      II. Identify genomic variants of uterine serous adenocarcinoma (including but not limited to&#xD;
      p53) with treatment response to ribonucleotide reductase inhibitors such as triapine using&#xD;
      whole exome sequencing (WES).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive triapine IV over 2 hours on day 1 in the absence of unacceptable toxicity.&#xD;
      Patients then undergo surgical resection and tissue collection 6-8 hours after the initiation&#xD;
      of the triapine infusion. Patients also undergo biopsy and collection of blood samples on&#xD;
      study.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 42 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Anticipated">November 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 10, 2023</primary_completion_date>
  <phase>Early 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>Pharmacodynamic response</measure>
    <time_frame>Up to 6-8 hours post-triapine infusion</time_frame>
    <description>Pharmacodynamic response rate will be estimated as the proportion of evaluable patients who achieve pharmacodynamic response defined as a decrease in phospho-histone H3 (pHH3) immunoscore of &gt;= 1 from baseline to post-exposure of intravenous triapine for each patient. The corresponding 95% confidence interval will be provided.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to day 42</time_frame>
    <description>Dose-limiting toxicities (DLTs), as listed by Common Terminology Criteria for Adverse Events (CTCAE), version 5, are defined as any pre-surgical grade 3 or higher non-hematologic toxicity or grade 4 neutropenia, neutropenic fever, or thrombocytopenia within 24 hours of triapine administration. Toxicity will be tabulated by type and grade.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) analysis</measure>
    <time_frame>Baseline, 5 minutes before end of triapine infusion, 6-8 hours post-infusion (at time of surgical tissue resection), and 24 hours post-infusion</time_frame>
    <description>End of infusion plasma concentrations represent maximum concentration (Cmax) and will be compared with historical data. Post-triapine plasma and tissue concentrations will generate plasma to tissue ratios, which represent the tissue partitioning coefficient, a useful PK parameter.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Single-cell transcriptome analysis</measure>
    <time_frame>Baseline, post-triapine infusion, surgical resection</time_frame>
    <description>Single-cell transcriptome analysis will be conducted to quantify changes in gene expression following triapine treatment. Changes of gene expression will be correlated with immunohistochemistry (IHC) endpoints of cell cycle arrest.</description>
  </other_outcome>
  <other_outcome>
    <measure>Whole exome sequencing (WES) analysis</measure>
    <time_frame>Baseline</time_frame>
    <description>WES will be used to identify genomic variants of uterine serous adenocarcinoma (including but not limited to p53) that can predict the treatment response to triapine.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Endometrial Serous Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment (triapine, surgical resection)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive triapine IV over 2 hours on day 1 in the absence of unacceptable toxicity. Patients then undergo surgical resection and tissue collection 6-8 hours after the initiation of the triapine infusion. Patients also undergo biopsy and collection of blood samples on study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy</intervention_name>
    <description>Undergo biopsy</description>
    <arm_group_label>Treatment (triapine, surgical resection)</arm_group_label>
    <other_name>BIOPSY_TYPE</other_name>
    <other_name>Bx</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of tissue and blood samples</description>
    <arm_group_label>Treatment (triapine, surgical resection)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resection</intervention_name>
    <description>Undergo surgical resection</description>
    <arm_group_label>Treatment (triapine, surgical resection)</arm_group_label>
    <other_name>Surgical Resection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triapine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (triapine, surgical resection)</arm_group_label>
    <other_name>3-aminopyridine-2-carboxaldehyde thiosemicarbazone</other_name>
    <other_name>3-AP</other_name>
    <other_name>3-Apct</other_name>
    <other_name>OCX-0191</other_name>
    <other_name>OCX-191</other_name>
    <other_name>OCX191</other_name>
    <other_name>PAN-811</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed uterine corpus serous adenocarcinoma&#xD;
&#xD;
          -  Patients must be planned for surgical hysterectomy and operative staging&#xD;
&#xD;
          -  Patients must have adequate archival tissue old obtained within 8 weeks of step 1&#xD;
             registration OR have sufficient tumor tissue and be willing to undergo an endometrial&#xD;
             pipelle biopsy prior to beginning study treatment&#xD;
&#xD;
          -  Patients must have adequate primary tumor volume, as determined by imaging (e.g.,&#xD;
             computed tomography [CT], ultrasound, magnetic resonance imaging [MRI]) at eligibility&#xD;
             screening, to accommodate research specimen collections in addition to clinical&#xD;
             pathology evaluation&#xD;
&#xD;
          -  Patients must not have received any prior anticancer treatment for endometrial cancer&#xD;
&#xD;
          -  Patients must be &gt;= 18 years old. Because no dosing or adverse event data are&#xD;
             currently available on the use of triapine in patients &lt; 18 years of age, children are&#xD;
             excluded from this study&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =&lt;&#xD;
             2 (Karnofsky &gt;= 60%)&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,000/mcL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL&#xD;
&#xD;
          -  Hemoglobin &gt;= 9.0 g/dL&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 3 x institutional ULN&#xD;
&#xD;
          -  International normalized ratio (INR) =&lt; 2&#xD;
&#xD;
          -  Creatinine =&lt; 1.5 x institutional ULN OR glomerular filtration rate (GFR) &gt;= 60&#xD;
             mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function&#xD;
             values, no lower than 30 mL/min/1.73 m^2&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral&#xD;
             therapy with undetectable viral load within 6 months are eligible for this trial&#xD;
&#xD;
          -  For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral&#xD;
             load must be undetectable on suppressive therapy, if indicated&#xD;
&#xD;
          -  Patients with a history of hepatitis C virus (HCV) infection must have been treated&#xD;
             and cured. For patients with HCV infection who are currently on treatment, they are&#xD;
             eligible if they have an undetectable HCV viral load&#xD;
&#xD;
          -  Patients with a prior or concurrent malignancy whose natural history or treatment does&#xD;
             not have the potential to interfere with the safety or efficacy assessment of the&#xD;
             investigational regimen are eligible for this trial&#xD;
&#xD;
          -  Patients with known history or current symptoms of cardiac disease, or history of&#xD;
             treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac&#xD;
             function using the New York Heart Association Functional Classification. To be&#xD;
             eligible for this trial, patients should be class 2B or better&#xD;
&#xD;
          -  Patients of childbearing potential must have a negative pregnancy test result prior to&#xD;
             beginning study treatment&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
             Participants with impaired decision-making capacity (IDMC) are not eligible as there&#xD;
             is limited likelihood of direct benefit for participants in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for&#xD;
             nitrosoureas or mitomycin C) prior to entering the study&#xD;
&#xD;
          -  Patients who have not recovered from adverse events due to prior anti-cancer therapy&#xD;
             (i.e., have residual toxicities &gt; grade 1) with the exception of alopecia&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents&#xD;
&#xD;
          -  Patients who have known brain metastases, as they are not candidates for surgery&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to triapine&#xD;
&#xD;
          -  Patients receiving any medications or substances that are inhibitors or inducers of&#xD;
             triapine, as well as medications known to be associated with methemoglobinemia, are&#xD;
             ineligible. Triapine drug interactions have not yet been identified. As part of the&#xD;
             enrollment/informed consent procedures, the patient will be counseled on the risk of&#xD;
             interactions with other agents, and what to do if new medications need to be&#xD;
             prescribed or if the patient is considering a new over-the-counter medicine or herbal&#xD;
             product&#xD;
&#xD;
          -  Patients with uncontrolled intercurrent illness&#xD;
&#xD;
          -  Patients with psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency are not eligible.&#xD;
             Patients at risk for G6PD deficiency must be screened prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca L Stone</last_name>
    <role>Principal Investigator</role>
    <affiliation>JHU Sidney Kimmel Comprehensive Cancer Center LAO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UM Sylvester Comprehensive Cancer Center at Coral Gables</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UM Sylvester Comprehensive Cancer Center at Deerfield Beach</name>
      <address>
        <city>Deerfield Beach</city>
        <state>Florida</state>
        <zip>33442</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UM Sylvester Comprehensive Cancer Center at Plantation</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Rebecca L. Stone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CTOclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Sadia Sayeed</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</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>
    <mesh_term>Cystadenocarcinoma, Serous</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.</ipd_description>
    <ipd_url>https://grants.nih.gov/policy/sharing.htm</ipd_url>
  </patient_data>
  <!-- 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/NCT04494113
org study id: NCI-2020-05457
secondary id: NCI-2020-05457
secondary id: 10401
secondary id: 10401
secondary id: UM1CA186691
nct id: NCT04494113
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This early phase I trial investigates the response to the anti-cancer drug, triapine, in
      uterine cancers by using markers from tissue samples at the time of removal of the uterus,
      ovaries, and fallopian tubes (hysterectomy and bilateral salpingo-oophorectomy). Triapine may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding
      triapine to the usual approach of surgery followed by chemotherapy alone or in combination
      with radiation therapy may help to slow the growth of uterine cancer.
PRIMARY OBJECTIVE:

      I. Determine whether intravenous (IV) triapine 25 mg/m^2 will induce cell cycle arrest as
      measured by phospho-histone H3 (pHH3) in uterine serous adenocarcinoma cells removed at the
      time of hysterectomy.

      SECONDARY OBJECTIVES:

      I. Determine whether a preoperative dose of intravenous triapine 25 mg/m^2 can be safely
      given prior to hysterectomy and staging for uterine serous adenocarcinoma.

      II. Determine whether changes in cyclin D/E and Ki-67 protein expression are detectable using
      immunohistochemistry pre- and post-triapine treatment in uterine serous adenocarcinomas.

      III. Evaluate plasma and tissue triapine concentrations.

      EXPLORATORY OBJECTIVES:

      I. Determine the feasibility of using single-cell transcriptome analysis to quantify changes
      in gene expression following triapine treatment and to evaluate their concordance with
      immunohistochemistry (IHC) endpoints of cell cycle arrest.

      II. Identify genomic variants of uterine serous adenocarcinoma (including but not limited to
      p53) with treatment response to ribonucleotide reductase inhibitors such as triapine using
      whole exome sequencing (WES).

      OUTLINE:

      Patients receive triapine IV over 2 hours on day 1 in the absence of unacceptable toxicity.
      Patients then undergo surgical resection and tissue collection 6-8 hours after the initiation
      of the triapine infusion. Patients also undergo biopsy and collection of blood samples on
      study.

      After completion of study treatment, patients are followed up for 42 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacodynamic response
time frame: Up to 6-8 hours post-triapine infusion
description: Pharmacodynamic response rate will be estimated as the proportion of evaluable patients who achieve pharmacodynamic response defined as a decrease in phospho-histone H3 (pHH3) immunoscore of >= 1 from baseline to post-exposure of intravenous triapine for each patient. The corresponding 95% confidence interval will be provided.
measure: Incidence of adverse events
time frame: Up to day 42
description: Dose-limiting toxicities (DLTs), as listed by Common Terminology Criteria for Adverse Events (CTCAE), version 5, are defined as any pre-surgical grade 3 or higher non-hematologic toxicity or grade 4 neutropenia, neutropenic fever, or thrombocytopenia within 24 hours of triapine administration. Toxicity will be tabulated by type and grade.
measure: Pharmacokinetic (PK) analysis
time frame: Baseline, 5 minutes before end of triapine infusion, 6-8 hours post-infusion (at time of surgical tissue resection), and 24 hours post-infusion
description: End of infusion plasma concentrations represent maximum concentration (Cmax) and will be compared with historical data. Post-triapine plasma and tissue concentrations will generate plasma to tissue ratios, which represent the tissue partitioning coefficient, a useful PK parameter.
measure: Single-cell transcriptome analysis
time frame: Baseline, post-triapine infusion, surgical resection
description: Single-cell transcriptome analysis will be conducted to quantify changes in gene expression following triapine treatment. Changes of gene expression will be correlated with immunohistochemistry (IHC) endpoints of cell cycle arrest.
measure: Whole exome sequencing (WES) analysis
time frame: Baseline
description: WES will be used to identify genomic variants of uterine serous adenocarcinoma (including but not limited to p53) that can predict the treatment response to triapine.
arm group label: Treatment (triapine, surgical resection)
arm group type: Experimental
description: Patients receive triapine IV over 2 hours on day 1 in the absence of unacceptable toxicity. Patients then undergo surgical resection and tissue collection 6-8 hours after the initiation of the triapine infusion. Patients also undergo biopsy and collection of blood samples on study.
intervention type: Procedure
intervention name: Biopsy
description: Undergo biopsy
arm group label: Treatment (triapine, surgical resection)
other name: BIOPSY_TYPE
other name: Bx
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of tissue and blood samples
arm group label: Treatment (triapine, surgical resection)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Procedure
intervention name: Resection
description: Undergo surgical resection
arm group label: Treatment (triapine, surgical resection)
other name: Surgical Resection
intervention type: Drug
intervention name: Triapine
description: Given IV
arm group label: Treatment (triapine, surgical resection)
other name: 3-aminopyridine-2-carboxaldehyde thiosemicarbazone
other name: 3-AP
other name: 3-Apct
other name: OCX-0191
other name: OCX-191
other name: OCX191
other name: PAN-811
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca L Stone
role: Principal Investigator
affiliation: JHU Sidney Kimmel Comprehensive Cancer Center LAO
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Cystadenocarcinoma, Serous
sharing ipd: Yes
ipd description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
ipd url: https://grants.nih.gov/policy/sharing.htm