<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/NCT03284723</url>
  </required_header>
  <id_info>
    <org_study_id>C0541001</org_study_id>
    <secondary_id>2017-002538-22</secondary_id>
    <nct_id>NCT03284723</nct_id>
  </id_info>
  <brief_title>PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors</brief_title>
  <official_title>A Phase 1 Dose Escalation Study Evaluating the Safety and Tolerability of PF-06804103 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive and Negative Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</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 study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses&#xD;
      of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2&#xD;
      positive only and gastric were studied in Part 1A only). The study will expand to look at&#xD;
      selected doses in patients with HER2 positive and negative breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</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 Dose-Limiting Toxicities (DLTs)</measure>
    <time_frame>Part 1A: Baseline through Day 21; Part 1B: Baseline through Day 28</time_frame>
    <description>First cycle DLTs in order to determine the maximum tolerated dose of monotherapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)</measure>
    <time_frame>Part 1 and Part 2: Baseline through LSLV (up to approximately 2 years)</time_frame>
    <description>Assessment of all available safety data in order to determine the safety and tolerability of monotherapy and combination therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participant with objective response</measure>
    <time_frame>Part 2: Baseline through LSLV (up to approximately 2 years)</time_frame>
    <description>To investigate preliminary antitumor activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Response (DR)</measure>
    <time_frame>Part 2: Baseline through LSLV (up to approximately 2 years)</time_frame>
    <description>To investigate preliminary antitumor activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Part 2: Baseline through LSLV (up to approximately 2 years)</time_frame>
    <description>To investigate preliminary antitumor activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Tumor Progression (TTP)</measure>
    <time_frame>Part 2: Baseline through LSLV (up to approximately 2 years)</time_frame>
    <description>To investigate preliminary antitumor activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) - Part 1A</measure>
    <time_frame>Cycle 1 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) - Part 2A</measure>
    <time_frame>Cycles 1 &amp; 4 on Day 1 at 0, 1, 4 hours, and on Day 15; Cycles 2 &amp; 3 on Day 1 at 0 &amp; 1 hour; Every subsequent cycle pn Day 1 at 0 and 1 hour (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) Part B</measure>
    <time_frame>Cycles 1 &amp; 4 on Day 1 at 0, 1, 4, &amp; 24 hours, Day 4, Day 8 &amp; Day 15 at 0 &amp; 1 hour; Cycles 2 &amp; 3 on Day 1 at 0 &amp; 1 hour, Cycles 2 &amp; 3 on Day 15 at 0 &amp; 1 hour; Every subsequent cycle on Day 1 at 0 &amp; 1 hour (cycle is 28 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum observed concentration (Tmax) - Part 1A</measure>
    <time_frame>Cycles 1 &amp; 4 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycles 2 &amp; 3 Day 1: 0 and 1 hour, and Day 1: 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum observed concentration (Tmax) - Part 2A</measure>
    <time_frame>Cycles 1 &amp; 4 on Day 1 at 0, 1, 4 hours, and on Day 15; Cycles 2 &amp; 3 on Day 1 at 0 &amp; 1 hour; Every subsequent cycle pn Day 1 at 0 and 1 hour (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum observed concentration (Tmax) - Part B</measure>
    <time_frame>Cycles 1 &amp; 4 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycles 2 &amp; 3 Day 1: 0 and 1 hour, and Day 1: 0 and 1 hour of subsequent cycles (cycle is 28 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from time zero to end of dosing interval (AUCtau) Part 1A</measure>
    <time_frame>Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from time zero to end of dosing interval (AUCtau) Part 2A</measure>
    <time_frame>Cycles 1 and 4: Day 1: 0, 1, 4 hours, and Day 15; Cycle 2 and 3, Day 1: 0 and 1 hour, and Day 1 at 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from time zero to end of dosing interval (AUCtau) Part B</measure>
    <time_frame>Cycles 1 and 4: Day 1: 0, 1, 4 hours, Day 2, Day 4, Day 8 and Day 15 at 0 and 1 hour; Cycle 2 and 3, Day 1: 0 and 1 hour and Day 15 at 0 and 1 hour, and Day 1 at 0 and 1 hour of subsequent cycles (cycle is 28 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 1A</measure>
    <time_frame>Cycle 1 &amp; Cycle 4 Day 1: 0, 1, 4, &amp; 24 hours, Day 4, Day 8 &amp; Day 15, Cycles 2 &amp; 3 Day 1: 0 &amp; 1 hour, and Day 1 at 0 &amp; 1 hour of subsequent cycles (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 2A</measure>
    <time_frame>Cycle 1 &amp; Cycle 4 Day 1: 0, 1, 4 hours, &amp; Day 15, Cycles 2 &amp; 3 Day 1: 0 &amp; 1 hour, and Day 1 at 0 &amp; 1 hour of subsequent cycles (cycle is 21 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part B</measure>
    <time_frame>Cycle 1 &amp; Cycle 4 Day 1: 0, 1, 4, &amp; 24 hours, Day 4, Day 8 &amp; Day 15, Cycles 2 &amp; 3 Day 1: 0 &amp; 1 hour, and Day 1 at 0 &amp; 1 hour of subsequent cycles (cycle is 28 days) up to 24 months</time_frame>
    <description>To understand single and multiple dose parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and titers of anti-drug antibodies Part A</measure>
    <time_frame>Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsequent cycle (each cycle is 21 days) up to 24 months</time_frame>
    <description>To evaluate the immunogenicity of the drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and titers of anti-drug antibodies Part B</measure>
    <time_frame>Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 28 days) up to 24 months</time_frame>
    <description>To evaluate the immunogenicity of the drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and titers of neutralizing antibodies Part A</measure>
    <time_frame>Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 21 days) up to 24 months</time_frame>
    <description>To evaluate the immunogenicity of the drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and titers of neutralizing antibodies Part B</measure>
    <time_frame>Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 28 days) up to 24 months</time_frame>
    <description>To evaluate the immunogenicity of the drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant with objective response</measure>
    <time_frame>Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months</time_frame>
    <description>Document antitumor activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months</time_frame>
    <description>Document antitumor activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HER2 expression level in patients with documented anti-tumor activity</measure>
    <time_frame>Baseline and Cycle 3 Day 1 (for monotherapy: each cycle is 21 days; for combination therapy: each cycle is 28 days)</time_frame>
    <description>Explore preliminary antitumor activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DR)</measure>
    <time_frame>Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months</time_frame>
    <description>Document antitumor activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Tumor Progression (TTP)</measure>
    <time_frame>Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months</time_frame>
    <description>Document antitumor activity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>PF-06804103</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06804103+Combination Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06804103</intervention_name>
    <description>Dose Escalation Part - 1A Dose Expansion Part - 2A</description>
    <arm_group_label>PF-06804103</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06804103 + Palbociclib +Letrozole</intervention_name>
    <description>Dose Escalation - Part 1B Dose Expansion - Part 2B</description>
    <arm_group_label>PF-06804103+Combination Regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or&#xD;
             for which no standard therapy is available (Part 1A only)&#xD;
&#xD;
          -  HER2 positive and negative breast cancer (Part 2A)&#xD;
&#xD;
          -  HER2 negative breast cancer (Part 1B &amp; Part 2B)&#xD;
&#xD;
          -  Performance status of 0 or 1&#xD;
&#xD;
          -  Adequate bone marrow, kidney and liver function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known CNS disease including, but not limited to, metastases&#xD;
&#xD;
          -  History of exposure to certain cumulative doses of anthracyclines&#xD;
&#xD;
          -  Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy&#xD;
&#xD;
          -  Active and clinically significant bacterial, fungal, or viral infection&#xD;
&#xD;
          -  Abnormal cardiac function defined by a LVEF &lt;50% by ECHO or MUGA&#xD;
&#xD;
          -  Patients with previous history or active interstitial lung disease or pulmonary&#xD;
             fibrosis, or a history of other clinically significant lung diseases&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner-University Medical Center Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center - North Campus</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Health (main campus)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica - UCLA Medical Center and Orthopaedic Hospital</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Dept of Medicine - Hematology/Oncology, Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Health, Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital Inc.- GCS/Athens</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Cancer Care - Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital, Inc. - GCS/Northside</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital,Inc.-GCS /Blairsville</name>
      <address>
        <city>Blairsville</city>
        <state>Georgia</state>
        <zip>30512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital, Inc. - GCS/Canton</name>
      <address>
        <city>Canton</city>
        <state>Georgia</state>
        <zip>30114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Cancer Care - Cumming</name>
      <address>
        <city>Cumming</city>
        <state>Georgia</state>
        <zip>30041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital, Inc.-GCS/Stemmer</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Hematology-Oncology Associates - Duluth</name>
      <address>
        <city>Duluth</city>
        <state>Georgia</state>
        <zip>30096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Cancer Care - Lake Spivey</name>
      <address>
        <city>Jonesboro</city>
        <state>Georgia</state>
        <zip>30236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Hematology-Oncology Associates- Lawrenceville</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital, Inc. - GCS/Macon</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital, Inc. GCS/Kennestone</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology West, PC dba Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah, Huntsman Cancer Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah, Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chris O'Brien Lifehouse</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University</name>
      <address>
        <city>Macquarie University</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio-Sanitaria Territoriale Monza</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas U. O. Oculistica</name>
      <address>
        <city>Razzano</city>
        <state>Milan</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS, Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione di Cardiologia - Istituto Europeo di Oncologia Divisione di Medicina Nucleare</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Clinica UZI 4D&quot;</name>
      <address>
        <city>Pyatigorsk</city>
        <state>Stavropol Region</state>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Healthcare Institution &quot;Clinical hospital &quot;RZD-Medicine&quot; of Saint-Petersburg</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quirón Madrid</name>
      <address>
        <city>Pozuelo de Alarcón</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C0541001</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2</keyword>
  <keyword>PF-06804103</keyword>
  <keyword>ADC</keyword>
  <keyword>breast cancer</keyword>
  <keyword>neoplasms</keyword>
  <keyword>solid tumors</keyword>
  <keyword>human epidermal growth receptor 2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Letrozole</mesh_term>
    <mesh_term>Palbociclib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>July 21, 2022</submitted>
    <returned>June 12, 2023</returned>
    <submitted>July 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03284723
org study id: C0541001
secondary id: 2017-002538-22
nct id: NCT03284723
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
      of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2
      positive only and gastric were studied in Part 1A only). The study will expand to look at
      selected doses in patients with HER2 positive and negative breast cancer.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with Dose-Limiting Toxicities (DLTs)
time frame: Part 1A: Baseline through Day 21; Part 1B: Baseline through Day 28
description: First cycle DLTs in order to determine the maximum tolerated dose of monotherapy.
measure: Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
time frame: Part 1 and Part 2: Baseline through LSLV (up to approximately 2 years)
description: Assessment of all available safety data in order to determine the safety and tolerability of monotherapy and combination therapy
measure: Number of participant with objective response
time frame: Part 2: Baseline through LSLV (up to approximately 2 years)
description: To investigate preliminary antitumor activity
measure: Duration of Response (DR)
time frame: Part 2: Baseline through LSLV (up to approximately 2 years)
description: To investigate preliminary antitumor activity
measure: Progression-Free Survival (PFS)
time frame: Part 2: Baseline through LSLV (up to approximately 2 years)
description: To investigate preliminary antitumor activity
measure: Time to Tumor Progression (TTP)
time frame: Part 2: Baseline through LSLV (up to approximately 2 years)
description: To investigate preliminary antitumor activity
measure: Maximum Observed Concentration (Cmax) - Part 1A
time frame: Cycle 1 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Maximum Observed Concentration (Cmax) - Part 2A
time frame: Cycles 1 & 4 on Day 1 at 0, 1, 4 hours, and on Day 15; Cycles 2 & 3 on Day 1 at 0 & 1 hour; Every subsequent cycle pn Day 1 at 0 and 1 hour (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Maximum Observed Concentration (Cmax) Part B
time frame: Cycles 1 & 4 on Day 1 at 0, 1, 4, & 24 hours, Day 4, Day 8 & Day 15 at 0 & 1 hour; Cycles 2 & 3 on Day 1 at 0 & 1 hour, Cycles 2 & 3 on Day 15 at 0 & 1 hour; Every subsequent cycle on Day 1 at 0 & 1 hour (cycle is 28 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Time to reach maximum observed concentration (Tmax) - Part 1A
time frame: Cycles 1 & 4 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycles 2 & 3 Day 1: 0 and 1 hour, and Day 1: 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Time to reach maximum observed concentration (Tmax) - Part 2A
time frame: Cycles 1 & 4 on Day 1 at 0, 1, 4 hours, and on Day 15; Cycles 2 & 3 on Day 1 at 0 & 1 hour; Every subsequent cycle pn Day 1 at 0 and 1 hour (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Time to reach maximum observed concentration (Tmax) - Part B
time frame: Cycles 1 & 4 Day 1: 0, 1, 4, and 24 hours, Day 4, Day 8 and Day 15, Cycles 2 & 3 Day 1: 0 and 1 hour, and Day 1: 0 and 1 hour of subsequent cycles (cycle is 28 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Area under the curve from time zero to end of dosing interval (AUCtau) Part 1A
time frame: Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Area under the curve from time zero to end of dosing interval (AUCtau) Part 2A
time frame: Cycles 1 and 4: Day 1: 0, 1, 4 hours, and Day 15; Cycle 2 and 3, Day 1: 0 and 1 hour, and Day 1 at 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Area under the curve from time zero to end of dosing interval (AUCtau) Part B
time frame: Cycles 1 and 4: Day 1: 0, 1, 4 hours, Day 2, Day 4, Day 8 and Day 15 at 0 and 1 hour; Cycle 2 and 3, Day 1: 0 and 1 hour and Day 15 at 0 and 1 hour, and Day 1 at 0 and 1 hour of subsequent cycles (cycle is 28 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 1A
time frame: Cycle 1 & Cycle 4 Day 1: 0, 1, 4, & 24 hours, Day 4, Day 8 & Day 15, Cycles 2 & 3 Day 1: 0 & 1 hour, and Day 1 at 0 & 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 2A
time frame: Cycle 1 & Cycle 4 Day 1: 0, 1, 4 hours, & Day 15, Cycles 2 & 3 Day 1: 0 & 1 hour, and Day 1 at 0 & 1 hour of subsequent cycles (cycle is 21 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part B
time frame: Cycle 1 & Cycle 4 Day 1: 0, 1, 4, & 24 hours, Day 4, Day 8 & Day 15, Cycles 2 & 3 Day 1: 0 & 1 hour, and Day 1 at 0 & 1 hour of subsequent cycles (cycle is 28 days) up to 24 months
description: To understand single and multiple dose parameters
measure: Incidence and titers of anti-drug antibodies Part A
time frame: Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsequent cycle (each cycle is 21 days) up to 24 months
description: To evaluate the immunogenicity of the drug
measure: Incidence and titers of anti-drug antibodies Part B
time frame: Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 28 days) up to 24 months
description: To evaluate the immunogenicity of the drug
measure: Incidence and titers of neutralizing antibodies Part A
time frame: Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 21 days) up to 24 months
description: To evaluate the immunogenicity of the drug
measure: Incidence and titers of neutralizing antibodies Part B
time frame: Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Day 1 of every subsquent cycle (each cycle is 28 days) up to 24 months
description: To evaluate the immunogenicity of the drug
measure: Number of participant with objective response
time frame: Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
description: Document antitumor activity
measure: Progression-Free Survival (PFS)
time frame: Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
description: Document antitumor activity
measure: HER2 expression level in patients with documented anti-tumor activity
time frame: Baseline and Cycle 3 Day 1 (for monotherapy: each cycle is 21 days; for combination therapy: each cycle is 28 days)
description: Explore preliminary antitumor activity
measure: Duration of Response (DR)
time frame: Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
description: Document antitumor activity
measure: Time to Tumor Progression (TTP)
time frame: Baseline and every 6 weeks (monotherapy) or every 8 weeks (combination therapy) until disease progression, unacceptable toxicity, or up to 24 months
description: Document antitumor activity
arm group label: PF-06804103
arm group type: Experimental
description: Study Treatment
arm group label: PF-06804103+Combination Regimen
arm group type: Experimental
description: Study Treatment
intervention type: Drug
intervention name: PF-06804103
description: Dose Escalation Part - 1A Dose Expansion Part - 2A
arm group label: PF-06804103
intervention type: Drug
intervention name: PF-06804103 + Palbociclib +Letrozole
description: Dose Escalation - Part 1B Dose Expansion - Part 2B
arm group label: PF-06804103+Combination Regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Australia
country: Italy
country: Korea, Republic of
country: Russian Federation
country: Spain
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C0541001
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Letrozole
mesh term: Palbociclib
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
submitted: July 21, 2022
returned: June 12, 2023
submitted: July 5, 2023