<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/NCT04428788</url>
  </required_header>
  <id_info>
    <org_study_id>CC-94676-PCA-001</org_study_id>
    <secondary_id>U1111-1251-9174</secondary_id>
    <nct_id>NCT04428788</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer</brief_title>
  <official_title>A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</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>
      The purpose of this study is to assess the safety, tolerability and preliminary efficacy of&#xD;
      CC-94676 in men with progressive metastatic castration resistant prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">February 27, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 27, 2023</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>Sequential 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 (AEs) evaluated using the NCI CTCAE v5.0 criteria</measure>
    <time_frame>From the time of consent at screening until 28 days after thesubject discontinues study treatment.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose-limiting toxicity (DLT)</measure>
    <time_frame>Up to 35 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-tolerated dose (NTD)</measure>
    <time_frame>Up to 35 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose (MTD)</measure>
    <time_frame>Up to 35 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants alive and not progressed at 6 months</measure>
    <time_frame>Up to 6 months after treatment is discontinued</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA Progression Free Survival (PFS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic progression free survival (rPFS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population</measure>
    <time_frame>Up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Area under the plasma concentration time curve (AUC)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Maximum plasma concentration (Cmax)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Time to Cmax (Tmax)</measure>
    <time_frame>Up to 35 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Administration of CC-94676 and CC1083611</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-94676</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Administration of CC-94676 and CC1083611</arm_group_label>
    <other_name>BMS-986365</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC1083611</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Administration of CC-94676 and CC1083611</arm_group_label>
    <other_name>BMS-986409</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have histologically or cytologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Progressed on androgen deprivation therapy (ADT) and at least one prior secondary&#xD;
             hormonal therapy approved for castration-resistant prostate cancer (CRPC)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with an androgen receptor (AR) degrader&#xD;
&#xD;
          -  Concurrent malignancy (present during screening) requiring treatment or history of&#xD;
             prior malignancy active within 1 year prior to the first dose of IP&#xD;
&#xD;
          -  Clinically significant venous thromboembolism within 3 months prior to the first dose&#xD;
             of IP&#xD;
&#xD;
          -  Any significant medical condition, such as uncontrolled infection, laboratory&#xD;
             abnormality, or psychiatric illness&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
    <phone>855-907-3286</phone>
    <email>Clinical.Trials@bms.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>First line of the email MUST contain the NCT# and Site #.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UAB</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Arnab Basu, Site 118</last_name>
      <phone>323-865-3000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305-5826</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandhya Srinivas, Site 116</last_name>
      <phone>650-725-2078</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medstar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Suthee Rapisuwon, Site 122</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sibley Memorial Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michael Carducci, Site 208</last_name>
      <phone>410-614-3977</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>M.D. Anderson Cancer Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Aparicio, Site 119</last_name>
      <phone>832-312-6124</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manish Patel, Site 103</last_name>
      <phone>941-377-9993</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory University.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacqueline Brown, Site 114</last_name>
      <phone>607-316-5695</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lewis Hall Singletary Oncology Center</name>
      <address>
        <city>Thomasville</city>
        <state>Georgia</state>
        <zip>31792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Josh Simmons, Site 121</last_name>
      <phone>229-551-8645</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1470</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Russell Szmulewitz, Site 110</last_name>
      <phone>773-702-7609</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Carducci, Site 108</last_name>
      <phone>410-614-3977</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Atish Choudhury, Site 104</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Of Michigan Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zachery Reichert, Site 117</last_name>
      <phone>815-353-5419</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>START Midwest</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nehal Lakhani, Site 102</last_name>
      <phone>616-954-5554</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mount Sinai - Icahn School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bobby Liaw, Site 112</last_name>
      <phone>212-604-6074</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Doctors Dermatology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karie Runcie, Site 109</last_name>
      <phone>212-305-8923</phone>
    </contact>
  </location>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Dana Rathkopf, Site 105</last_name>
      <phone>646-422-4379</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Armstrong, Site 106</last_name>
      <phone>919-668-8797</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Paul Palyca, Site 120</last_name>
      <phone>610-402-9543</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vivek Narayan, Site 113</last_name>
      <phone>215-360-0706</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ut Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin Courtney, Site 107</last_name>
      <phone>214-648-1948</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>South Texas Accelerated Research Therapeutics (START)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Drew Rasco, Site 101</last_name>
      <phone>210-593-5250</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson.Cancer Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Hawley, Site 115</last_name>
      <phone>206-606-2284</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hamid Emamekhoo, Site 111</last_name>
      <phone>513-862-1400</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>http://www.fda.gov/safety/medwatch/safetyinformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>http://www.BMSStudyConnect.com</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>CC-94676</keyword>
  <keyword>Castration-resistant prostate cancer</keyword>
  <keyword>Adenocarcinoma of the prostate</keyword>
  <keyword>Prostatic Neoplasms Castration-Resistant</keyword>
  <keyword>Neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link:&#xD;
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>See Plan Description</ipd_time_frame>
    <ipd_access_criteria>See Plan Description</ipd_access_criteria>
    <ipd_url>https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/</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/NCT04428788
org study id: CC-94676-PCA-001
secondary id: U1111-1251-9174
nct id: NCT04428788
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of
      CC-94676 in men with progressive metastatic castration resistant prostate cancer.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
time frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.
measure: Dose-limiting toxicity (DLT)
time frame: Up to 35 days
measure: Non-tolerated dose (NTD)
time frame: Up to 35 days
measure: Maximum tolerated dose (MTD)
time frame: Up to 35 days
measure: Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
time frame: Up to approximately 4 years
measure: Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
time frame: Up to approximately 4 years
measure: Duration of response (DOR)
time frame: Up to approximately 4 years
measure: Proportion of participants alive and not progressed at 6 months
time frame: Up to 6 months after treatment is discontinued
measure: PSA Progression Free Survival (PFS)
time frame: Up to approximately 4 years
measure: Radiographic progression free survival (rPFS)
time frame: Up to approximately 4 years
measure: Overall survival (OS)
time frame: Up to approximately 4 years
measure: Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population
time frame: Up to approximately 4 years
measure: Pharmacokinetics - Area under the plasma concentration time curve (AUC)
time frame: Up to 35 days
measure: Pharmacokinetics - Maximum plasma concentration (Cmax)
time frame: Up to 35 days
measure: Pharmacokinetics - Time to Cmax (Tmax)
time frame: Up to 35 days
arm group label: Administration of CC-94676 and CC1083611
arm group type: Experimental
intervention type: Drug
intervention name: CC-94676
description: Specified dose on specified days
arm group label: Administration of CC-94676 and CC1083611
other name: BMS-986365
intervention type: Drug
intervention name: CC1083611
description: Specified dose on specified days
arm group label: Administration of CC-94676 and CC1083611
other name: BMS-986409
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
phone: 855-907-3286
email: Clinical.Trials@bms.com
last name: First line of the email MUST contain the NCT# and Site #.
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
description: FDA Safety Alerts and Recalls
url: http://www.BMSStudyConnect.com
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
sharing ipd: Yes
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: See Plan Description
ipd access criteria: See Plan Description
ipd url: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/