<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/NCT03242382</url>
  </required_header>
  <id_info>
    <org_study_id>GEIS-51</org_study_id>
    <nct_id>NCT03242382</nct_id>
  </id_info>
  <brief_title>Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.</brief_title>
  <acronym>PalboSarc</acronym>
  <official_title>Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol de Investigacion en Sarcomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Espanol de Investigacion en Sarcomas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-randomized, open, two-cohort, phase II, multicenter national clinical trial. 20 sites in&#xD;
      Spain.&#xD;
&#xD;
      Cohort 1 includes soft-tissue sarcoma and osteosarcoma (21 patients), while Cohort 2 includes&#xD;
      chordoma patients only (19 patients).&#xD;
&#xD;
      Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive&#xD;
      days followed by 7 rest days to comprise a complete cycle of 28 days. Treatment will continue&#xD;
      until disease progression, development of unacceptable toxicity, non-compliance, withdrawal&#xD;
      of consent by the patient or investigator decision.&#xD;
&#xD;
      The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1&#xD;
      at 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>Progression free survival (PFS) rate</measure>
    <time_frame>At 6 months</time_frame>
    <description>Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>6 months</time_frame>
    <description>Efficacy measured through the overall response rate (ORR) (complete response [CR] and partial response [PR]), evaluated with RECIST 1.1 criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy measured through response according to Choi criteria measured through response according to Choi criteria:</measure>
    <time_frame>6 months</time_frame>
    <description>Efficacy measured through response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy measured through median PFS</measure>
    <time_frame>6 months</time_frame>
    <description>Efficacy measured through median PFS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy measured through PFS rate at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Efficacy measured through PFS rate at 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>Overall survival (OS) measured from the date of treatment initiation with palbociclib until date of death, whichever the cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR)</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical Benefit Rate (CBR). Patients having shown complete response, partial response, or disease stabilization during 6 months or more, showing clinical improvement symptoms, will be considered as having experienced clinical benefit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palbociclib safety profile</measure>
    <time_frame>1 year</time_frame>
    <description>Palbociclib safety profile, through the evaluation of adverse events (type, incidence, severity, timing of appearance, related causes) observed in physical explorations and laboratory tests. Toxicity will be assessed and tabulated using NCI-CTCAE 4.0 (first cohort; STS and osteosarcoma) and 5.0 (second cohort; chordomas).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Soft-tissue Sarcoma</condition>
  <condition>Osteosarcoma</condition>
  <condition>Chordoma</condition>
  <arm_group>
    <arm_group_label>Palbocilib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision</description>
    <arm_group_label>Palbocilib</arm_group_label>
    <other_name>Ibrance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Cohort 1: STS and osteosarcoma):&#xD;
&#xD;
          1. Over-expression of CDK4 (mRNA expression) and a low-to-normal p16 expression (mRNA&#xD;
             expression) measured in paraffin embedded tumor samples at study entry.&#xD;
&#xD;
          2. ECOG 0-1 at enrollment.&#xD;
&#xD;
          3. Diagnosis of soft tissue sarcoma or osteosarcoma (in both cases with metastasis or&#xD;
             locally advanced, unresectable).&#xD;
&#xD;
          4. Disease progression documented within 6 months prior to study entry.&#xD;
&#xD;
          5. Patients must have the following laboratory results:&#xD;
&#xD;
               -  ANC ≥ 1,500/mm3 (1.5 x 109/L);&#xD;
&#xD;
               -  Platelets ≥ 100,000/mm3 (100 x 109/L);&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL (90 g/L);&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min;&#xD;
&#xD;
               -  Total serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert's disease);&#xD;
&#xD;
               -  AST and/or ALT ≤ 3 x ULN (≤ 5.0 x ULN if liver metastases present);&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if bone or hepatic metastasis&#xD;
                  present);&#xD;
&#xD;
          6. Patients must have signed written informed consent to participate in the clinical&#xD;
             study, and to provide at least two paraffin embedded tumor blocks for the molecular&#xD;
             analyses at screening stage.&#xD;
&#xD;
          7. Biopsy at baseline if there are no archived tumor samples obtained within 3 months&#xD;
             prior to treatment initiation.&#xD;
&#xD;
          8. Patients must have received standard treatments for at least one, two or three lines&#xD;
             for advanced disease.&#xD;
&#xD;
          9. Age between 18 and 80 years (both ages included).&#xD;
&#xD;
         10. Measurable disease according to RECIST 1.1 criteria.&#xD;
&#xD;
         11. All patients (men and women) in fertile age must use an effective contraception method&#xD;
             during the entire treatment with palbociclib and for at least 90 days after the last&#xD;
             dose. Pregnancy must be ruled out through urine or blood test (negative pregnancy&#xD;
             test) for the inclusion in the study. Men must be informed to consider spermatic&#xD;
             preservation before treatment initiation due to infertility risks.&#xD;
&#xD;
        Exclusion Criteria (Cohort 1: STS and osteosarcoma):&#xD;
&#xD;
          1. Previous treatment with any anti CDK4 or immune checkpoint inhibitor.&#xD;
&#xD;
          2. Diagnosis of Ewing sarcoma or rhabdomyosarcoma.&#xD;
&#xD;
          3. Diagnosis of well differentiated/dedifferentiated liposarcoma.&#xD;
&#xD;
          4. Patients irradiated on the only target lesion available.&#xD;
&#xD;
          5. Patients having received more than three lines for advanced disease.&#xD;
&#xD;
          6. History of other neoplastic disease with the exception of basal cell carcinoma or in&#xD;
             situ cervical cancer adequately treated.&#xD;
&#xD;
          7. Serious cardiovascular disease (NYHA &gt;= 2)&#xD;
&#xD;
          8. Grade 3 or superior toxicity according to CTCAE 4.0 if the investigator considers this&#xD;
             can significantly interfere in the toxicity of the drug under study.&#xD;
&#xD;
          9. Patients not recovered from a previous toxicity to at least CTCAE Grade 1 due to prior&#xD;
             chemotherapy, radioactive, or biological cancer therapy (including monoclonal&#xD;
             antibodies).&#xD;
&#xD;
         10. Patients not recovered from minor or major surgery or having undergone a major surgery&#xD;
             within the last 4 weeks prior to initiation of study treatment.&#xD;
&#xD;
         11. Central nervous system metastasis.&#xD;
&#xD;
         12. Pregnant or breastfeeding patients, or those expecting to conceive or father children&#xD;
             within the projected duration of treatment.&#xD;
&#xD;
         13. Foods or drugs known as CYP3A4 inhibitors/inducers; CYP3A4 substrates with narrow&#xD;
             therapeutic windows, or known to prolong QTc interval.&#xD;
&#xD;
         14. Major surgery, chemotherapy, radiotherapy, any agent under investigation, or other&#xD;
             antineoplastic therapy within 4 weeks prior to inclusion. Patients having received a&#xD;
             previous radiotherapy ≥25% of bone marrow are not eligible, regardless of when it was&#xD;
             received.&#xD;
&#xD;
         15. QTc &gt; 480 ms; personal or family history of long or short QT syndrome, Brugada&#xD;
             syndrome or known history of QTc prolongation, or Torsades de Pointes (TdP).&#xD;
&#xD;
         16. Any of the following situations within 6 months prior to study drug administration:&#xD;
             myocardial infarction, serious/unstable angina, current cardiac dysrhythmias Grade ≥ 2&#xD;
             NCI-CTCAE version 4.0, atrial fibrillation of any grade, bypass graft in&#xD;
             coronary/peripheral artery, symptomatic congestive cardiac failure, cerebrovascular&#xD;
             accident including transient ischemic attack, or symptomatic pulmonary embolism.&#xD;
&#xD;
         17. Known hypersensitivity to any PD 0332991 or excipients.&#xD;
&#xD;
         18. Active or recent suicide attempt or behavior.&#xD;
&#xD;
        Inclusion Criteria (Cohort 2: Chordomas):&#xD;
&#xD;
          1. Mutation of CDKN2A gen.&#xD;
&#xD;
          2. ECOG 0-1 at the time of inclusion.&#xD;
&#xD;
          3. Centrally confirmed diagnosis of chordoma (metastatic or locally advanced inoperable).&#xD;
&#xD;
          4. Disease progression according to RECIST 1.1, within the year prior to inclusion, to&#xD;
             previous treatment (surgery, radiotherapy or systemic treatment).&#xD;
&#xD;
          5. Patients are not candidates for salvage surgery or radiotherapy at the time of&#xD;
             inclusion.&#xD;
&#xD;
          6. Patients must have the following lab results:&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1,500/mm3 (1.5 x 109/L);&#xD;
&#xD;
               -  Platelets ≥ 100,000/mm3 (100 x 109/L);&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL (90 g/L);&#xD;
&#xD;
               -  Blood creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min;&#xD;
&#xD;
               -  Total blood bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert's disease);&#xD;
&#xD;
               -  AST and/or ALT ≤ 3 x ULN (≤ 5.0 x ULN if there is liver metastasis);&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if there is bone or liver&#xD;
                  metastasis);&#xD;
&#xD;
          7. The patients must have signed the written consent to participate in the clinical&#xD;
             study, and to provide the tumor blocks in paraffin for the molecular analysis of the&#xD;
             screening phase.&#xD;
&#xD;
          8. Biopsy at baseline if there are no archive tumor samples obtained in the 3 months&#xD;
             prior to starting treatment. If there are tumor samples within this period, there&#xD;
             should not be subsequent treatments.&#xD;
&#xD;
          9. Patients may have received up to 3 previous lines of systemic treatment.&#xD;
&#xD;
         10. Age between 18 and 80 years (both ages included).&#xD;
&#xD;
         11. Measurable disease according to RECIST 1.1 criteria.&#xD;
&#xD;
         12. All patients (male and female) of childbearing potential must use effective&#xD;
             contraception throughout treatment with palbociclib and for at least 90 days after the&#xD;
             last dose. Pregnancy must be ruled out by urine or blood test (negative pregnancy&#xD;
             test) for inclusion in the study. Men should be told to consider sperm preservation&#xD;
             before starting treatment due to the risks of infertility.&#xD;
&#xD;
        Exclusion Criteria (Cohort 2: Chordomas):&#xD;
&#xD;
          1. Prior treatment with any anti-CDK4 or immune checkpoint inhibitors.&#xD;
&#xD;
          2. Diagnosis other than chordoma according to central review.&#xD;
&#xD;
          3. Patients irradiated in the only available target lesion.&#xD;
&#xD;
          4. Patients who have received more than three lines for advanced disease.&#xD;
&#xD;
          5. History of other neoplastic disease with the exception of adequately treated basal&#xD;
             cell carcinoma or cervical cancer in situ. This criterion will be individually&#xD;
             assessed with the research team.&#xD;
&#xD;
          6. Severe cardiovascular disease (NYHA &gt;= 2).&#xD;
&#xD;
          7. Grade 3 toxicity or higher according to CTCAE 5.0 if, in the investigator's opinion,&#xD;
             it can significantly interfere with the toxicity of the drug under study.&#xD;
&#xD;
          8. Patients who have not recovered from previous toxicity up to CTCAE grade 1 due to&#xD;
             previous antineoplastic treatment with chemotherapy, radiotherapy, or biological&#xD;
             therapy (including monoclonal antibodies).&#xD;
&#xD;
          9. Patients who have not recovered from minor or major surgery or who have had major&#xD;
             surgery within 4 weeks prior to the start of study treatment.&#xD;
&#xD;
         10. Metastases in the central nervous system.&#xD;
&#xD;
         11. Patients who are pregnant or lactating, or who expect to conceive children during the&#xD;
             treatment period.&#xD;
&#xD;
         12. Foods or drugs known to be inhibitors/inducers of CYP3A4; CYP3A4 substrates with&#xD;
             narrow therapeutic windows, or known to prolong the QTc interval.&#xD;
&#xD;
         13. Major surgery, chemotherapy, radiation therapy, any investigational agent, or other&#xD;
             antineoplastic therapy within 4 weeks prior to enrollment. Patients who have received&#xD;
             prior radiation therapy to ≥25% of the bone marrow are not eligible, regardless of&#xD;
             when received.&#xD;
&#xD;
         14. QTc &gt; 480 ms; personal or family history of long or short QT syndrome, Brugada&#xD;
             syndrome, or known history of QTc prolongation, or Torsades de Pointes (TdP).&#xD;
&#xD;
         15. Any of the following within 6 months prior to study drug administration: Myocardial&#xD;
             infarction, severe/unstable angina, current NCI-CTCAE version 5.0 Grade ≥ 2 cardiac&#xD;
             dysrhythmias, any grade atrial fibrillation, implant coronary/peripheral artery&#xD;
             pacemaker, symptomatic congestive heart failure, cerebrovascular accident including&#xD;
             transient ischemic attack, symptomatic pulmonary embolism, or interstitial lung&#xD;
             disease (ILD).&#xD;
&#xD;
         16. Known hypersensitivity to any PD 0332991 or excipients.&#xD;
&#xD;
         17. Active or recent suicidal intent or behavior.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Carrasco García, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospitales Universitarios Virgen del Rocío</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roberto Díaz, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario La Fe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Javier Martínez Trufero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Miguel Servet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yolanda Vidal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Complejo Hospitalario Universitario de Santiago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Luís García Llano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Central de Asturias</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio López-Pousa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diego Jara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario 12 de Octubre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabel Sevilla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Virgen de la Victoria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Javier Martín Broto</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Fundación Jiménez Díaz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Estival</last_name>
    <role>Principal Investigator</role>
    <affiliation>Germans Trias i Pujol Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luís Miguel de Sande</last_name>
    <role>Principal Investigator</role>
    <affiliation>Complejo Asistencial Universitario de León</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosa Álvarez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General Universitario Gregorio Marañón</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claudia Valverde</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari Vall d'Hebrón</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrés Redondo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario La Paz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josefina Cruz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario de Canarias</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Javier Lavernia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Valenciano de Oncología</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pablo Luna</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jerónimo Martínez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clínico Universitario Virgen de la Arrixaca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xavier García del Muro</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Català d'Oncología l'Hospitalet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio Casado</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital San Carlos, Madrid</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patricio Ledesma</last_name>
    <phone>+34 971439900</phone>
    <email>ensayos@sofpromed.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia Marcote</last_name>
    <phone>+34 660570948</phone>
    <email>cmarcote@sofpromed.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Lopez-Pousa, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Estival</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncología l'Hospitalet</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier García del Muro</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial Universitario de León</name>
      <address>
        <city>León</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luís Miguel de Sande</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Casado</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosa Álvarez</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diego Jara, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier Martín Broto</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrés Redondo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jerónimo Martínez</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabel Sevilla, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Luís García Llanos, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Espases</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pablo Luna</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>Santa Cruz De Tenerife</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josefina Cruz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yolanda Vidal, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene Carrasco García</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Díaz, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier Lavernia</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier Martínez Trufero, md</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>advanced</keyword>
  <keyword>sarcoma</keyword>
  <keyword>cdk4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Osteosarcoma</mesh_term>
    <mesh_term>Chordoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Palbociclib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03242382
org study id: GEIS-51
nct id: NCT03242382
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-randomized, open, two-cohort, phase II, multicenter national clinical trial. 20 sites in
      Spain.

      Cohort 1 includes soft-tissue sarcoma and osteosarcoma (21 patients), while Cohort 2 includes
      chordoma patients only (19 patients).

      Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive
      days followed by 7 rest days to comprise a complete cycle of 28 days. Treatment will continue
      until disease progression, development of unacceptable toxicity, non-compliance, withdrawal
      of consent by the patient or investigator decision.

      The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1
      at 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS) rate
time frame: At 6 months
description: Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.
measure: Overall response rate (ORR)
time frame: 6 months
description: Efficacy measured through the overall response rate (ORR) (complete response [CR] and partial response [PR]), evaluated with RECIST 1.1 criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
measure: Efficacy measured through response according to Choi criteria measured through response according to Choi criteria:
time frame: 6 months
description: Efficacy measured through response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
measure: Efficacy measured through median PFS
time frame: 6 months
description: Efficacy measured through median PFS.
measure: Efficacy measured through PFS rate at 3 months
time frame: 3 months
description: Efficacy measured through PFS rate at 3 months.
measure: Overall survival (OS)
time frame: 2 years
description: Overall survival (OS) measured from the date of treatment initiation with palbociclib until date of death, whichever the cause.
measure: Clinical Benefit Rate (CBR)
time frame: 6 months
description: Clinical Benefit Rate (CBR). Patients having shown complete response, partial response, or disease stabilization during 6 months or more, showing clinical improvement symptoms, will be considered as having experienced clinical benefit.
measure: Palbociclib safety profile
time frame: 1 year
description: Palbociclib safety profile, through the evaluation of adverse events (type, incidence, severity, timing of appearance, related causes) observed in physical explorations and laboratory tests. Toxicity will be assessed and tabulated using NCI-CTCAE 4.0 (first cohort; STS and osteosarcoma) and 5.0 (second cohort; chordomas).
arm group label: Palbocilib
arm group type: Experimental
description: Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days.
intervention type: Drug
intervention name: Palbociclib
description: Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision
arm group label: Palbocilib
other name: Ibrance
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Irene Carrasco García, MD
role: Study Director
affiliation: Hospitales Universitarios Virgen del Rocío
last name: Roberto Díaz, MD
role: Study Director
affiliation: Hospital Universitario La Fe
last name: Javier Martínez Trufero, MD
role: Principal Investigator
affiliation: Hospital Miguel Servet
last name: Yolanda Vidal, MD
role: Principal Investigator
affiliation: Complejo Hospitalario Universitario de Santiago
last name: Juan Luís García Llano, MD
role: Principal Investigator
affiliation: Hospital Universitario Central de Asturias
last name: Antonio López-Pousa, MD
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
last name: Diego Jara, MD
role: Principal Investigator
affiliation: Hospital Universitario 12 de Octubre
last name: Isabel Sevilla, MD
role: Principal Investigator
affiliation: Hospital Universitario Virgen de la Victoria
last name: Javier Martín Broto
role: Principal Investigator
affiliation: Hospital Universitario Fundación Jiménez Díaz
last name: Anna Estival
role: Principal Investigator
affiliation: Germans Trias i Pujol Hospital
last name: Luís Miguel de Sande
role: Principal Investigator
affiliation: Complejo Asistencial Universitario de León
last name: Rosa Álvarez
role: Principal Investigator
affiliation: Hospital General Universitario Gregorio Marañón
last name: Claudia Valverde
role: Principal Investigator
affiliation: Hospital Universitari Vall d'Hebrón
last name: Andrés Redondo
role: Principal Investigator
affiliation: Hospital Universitario La Paz
last name: Josefina Cruz
role: Principal Investigator
affiliation: Hospital Universitario de Canarias
last name: Javier Lavernia
role: Principal Investigator
affiliation: Instituto Valenciano de Oncología
last name: Pablo Luna
role: Principal Investigator
affiliation: Hospital Son Espases
last name: Jerónimo Martínez
role: Principal Investigator
affiliation: Hospital Clínico Universitario Virgen de la Arrixaca
last name: Xavier García del Muro
role: Principal Investigator
affiliation: Institut Català d'Oncología l'Hospitalet
last name: Antonio Casado
role: Principal Investigator
affiliation: Hospital San Carlos, Madrid
last name: Patricio Ledesma
phone: +34 971439900
email: ensayos@sofpromed.com
last name: Claudia Marcote
phone: +34 660570948
email: cmarcote@sofpromed.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Osteosarcoma
mesh term: Chordoma
mesh term: Palbociclib
sharing ipd: Undecided