<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/NCT04504513</url>
  </required_header>
  <id_info>
    <org_study_id>G1T28-501</org_study_id>
    <nct_id>NCT04504513</nct_id>
  </id_info>
  <brief_title>Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer</brief_title>
  <official_title>Expanded Access Program: Trilaciclib for Chemotherapy-induced Myelosuppression in Patients Receiving Chemotherapy for Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>G1 Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bionical Emas</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>G1 Therapeutics, Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this expanded access protocol is to provide access to trilaciclib for&#xD;
      chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for&#xD;
      small cell lung cancer (SCLC).&#xD;
&#xD;
      Patients will receive trilaciclib intravenously as a 30-minute infusion prior to chemotherapy&#xD;
      dosing and on each day that chemotherapy is administered.&#xD;
&#xD;
      Supplementary to providing access to trilaciclib, this expanded access program will also&#xD;
      capture Real World Data to help inform subsequent trilaciclib development.&#xD;
&#xD;
      Requests for access to trilaciclib will be managed by Bionical Emas. G1 Therapeutics will&#xD;
      review eligibility of, as well as complete a medical review of, each patient access request.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Myelosuppression Adult</condition>
  <condition>Chemotherapeutic Toxicity</condition>
  <condition>Small Cell Lung Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trilaciclib</intervention_name>
    <description>Trilaciclib is a highly potent, selective, and reversible cyclin-dependent kinase 4/6 inhibitor administered intravenously prior to chemotherapy for chemotherapy-induced myelosuppression (CIM).&#xD;
In patients being treated for SCLC, trilaciclib transiently maintains G1 cell cycle arrest of hematopoietic stem and progenitor cells (HSPCs) in the bone marrow, thus protecting the cells from damage by cytotoxic chemotherapy (myelopreservation). This can reduce chemotherapy-related toxicity, making chemotherapy safer and more tolerable, and also reduce the need for rescue interventions that address the effects of myelosuppression, such as growth factors or blood and platelet transfusions.</description>
    <other_name>G1T28</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who require treatment with either intravenous etoposide + platinum&#xD;
             (carboplatin or cisplatin) ± an anti-PDL1 or anti-PD1 checkpoint inhibitor OR&#xD;
             intravenous topotecan&#xD;
&#xD;
          -  Pathologically confirmed diagnosis of SCLC&#xD;
&#xD;
          -  Extensive-stage or limited-stage SCLC; patients with limited-stage SCLC receiving&#xD;
             chemotherapy with concurrent radiation are NOT eligible.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  ECOG 0 to 2&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L at time of initiation of therapy in&#xD;
             this EAP&#xD;
&#xD;
          -  Platelet count ≥ 100 x 10^9/L at time of initiation of therapy in this EAP&#xD;
&#xD;
          -  Glomerular filtration rate (GFR) of ≥ 20 mL/minute at time of initiation of therapy in&#xD;
             this EAP&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5x ULN (upper limit normal) at time of initiation of therapy in&#xD;
             this EAP&#xD;
&#xD;
          -  AST or ALT ≤ 2.5x ULN (≤ 5x ULN in the presence of liver metastases) at time of&#xD;
             initiation of therapy in this EAP&#xD;
&#xD;
          -  QTcF interval ≤ 450 msec (males) or ≤ 470 msec (females) at screening (confirmed on&#xD;
             repeat). For patients with ventricular pacemakers, QTcF ≤ 500 msec&#xD;
&#xD;
          -  No personal or family history of long QT syndrome&#xD;
&#xD;
          -  Female patient is not lactating or currently pregnant, or plans to become pregnant,&#xD;
             while participating in this expanded access program&#xD;
&#xD;
          -  Female patients of reproductive potential agree to use effective contraception while&#xD;
             in the program and for at least 3 weeks after the last dose of trilaciclib&#xD;
&#xD;
          -  Patient agrees not to participate in another expanded access program or clinical trial&#xD;
             with an experimental treatment during participation in this EAP&#xD;
&#xD;
          -  Active clinical trial with trilaciclib is not available (or if available, it is not&#xD;
             appropriate) for the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients requiring treatment with oral etoposide or oral topotecan&#xD;
&#xD;
          -  Patients outside of the United States&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <link>
    <url>https://www.g1therapeutics.com/patients/access-to-investigational-therapies/</url>
    <description>G1 Therapeutics policy on expanded access</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Cancer</keyword>
  <keyword>Small Cell Lung Carcinoma</keyword>
  <keyword>Small Cell Lung Cancer Extensive Stage</keyword>
  <keyword>Small Cell Lung Cancer Limited Stage</keyword>
  <keyword>Small Cell Lung Cancer Metastatic</keyword>
  <keyword>Chemotherapy-induced Neutropenia</keyword>
  <keyword>Chemotherapy-induced Anemia</keyword>
  <keyword>CDK 4/6 Inhibitor</keyword>
  <keyword>trilaciclib</keyword>
  <keyword>etoposide</keyword>
  <keyword>carboplatin</keyword>
  <keyword>cisplatin</keyword>
  <keyword>topotecan</keyword>
  <keyword>checkpoint inhibitor</keyword>
  <keyword>myelosuppression</keyword>
  <keyword>cyclin-dependent kinase 4/6 inhibitor</keyword>
  <keyword>myelopreservation</keyword>
  <keyword>Real World Data</keyword>
  <keyword>chemotherapy-induced myelosuppression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04504513
org study id: G1T28-501
nct id: NCT04504513
lead sponsor: 
collaborator: 
The purpose of this expanded access protocol is to provide access to trilaciclib for
      chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for
      small cell lung cancer (SCLC).

      Patients will receive trilaciclib intravenously as a 30-minute infusion prior to chemotherapy
      dosing and on each day that chemotherapy is administered.

      Supplementary to providing access to trilaciclib, this expanded access program will also
      capture Real World Data to help inform subsequent trilaciclib development.

      Requests for access to trilaciclib will be managed by Bionical Emas. G1 Therapeutics will
      review eligibility of, as well as complete a medical review of, each patient access request.
expanded access type treatment: Yes
intervention type: Drug
intervention name: Trilaciclib
description: Trilaciclib is a highly potent, selective, and reversible cyclin-dependent kinase 4/6 inhibitor administered intravenously prior to chemotherapy for chemotherapy-induced myelosuppression (CIM).
In patients being treated for SCLC, trilaciclib transiently maintains G1 cell cycle arrest of hematopoietic stem and progenitor cells (HSPCs) in the bone marrow, thus protecting the cells from damage by cytotoxic chemotherapy (myelopreservation). This can reduce chemotherapy-related toxicity, making chemotherapy safer and more tolerable, and also reduce the need for rescue interventions that address the effects of myelosuppression, such as growth factors or blood and platelet transfusions.
other name: G1T28
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
url: https://www.g1therapeutics.com/patients/access-to-investigational-therapies/
description: G1 Therapeutics policy on expanded access
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma