search
Back to results

Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

Primary Purpose

Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Trilaciclib
Sponsored by
G1 Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Myelosuppression Adult focused on measuring Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Limited Stage, Small Cell Lung Cancer Metastatic, Chemotherapy-induced Neutropenia, Chemotherapy-induced Anemia, CDK 4/6 Inhibitor, trilaciclib, etoposide, carboplatin, cisplatin, topotecan, checkpoint inhibitor, myelosuppression, cyclin-dependent kinase 4/6 inhibitor, myelopreservation, Real World Data, chemotherapy-induced myelosuppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients who require treatment with either intravenous etoposide + platinum (carboplatin or cisplatin) ± an anti-PDL1 or anti-PD1 checkpoint inhibitor OR intravenous topotecan
  • Pathologically confirmed diagnosis of SCLC
  • Extensive-stage or limited-stage SCLC; patients with limited-stage SCLC receiving chemotherapy with concurrent radiation are NOT eligible.
  • Age ≥ 18 years
  • ECOG 0 to 2
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L at time of initiation of therapy in this EAP
  • Platelet count ≥ 100 x 10^9/L at time of initiation of therapy in this EAP
  • Glomerular filtration rate (GFR) of ≥ 20 mL/minute at time of initiation of therapy in this EAP
  • Total bilirubin ≤ 1.5x ULN (upper limit normal) at time of initiation of therapy in this EAP
  • AST or ALT ≤ 2.5x ULN (≤ 5x ULN in the presence of liver metastases) at time of initiation of therapy in this EAP
  • QTcF interval ≤ 450 msec (males) or ≤ 470 msec (females) at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF ≤ 500 msec
  • No personal or family history of long QT syndrome
  • Female patient is not lactating or currently pregnant, or plans to become pregnant, while participating in this expanded access program
  • Female patients of reproductive potential agree to use effective contraception while in the program and for at least 3 weeks after the last dose of trilaciclib
  • Patient agrees not to participate in another expanded access program or clinical trial with an experimental treatment during participation in this EAP
  • Active clinical trial with trilaciclib is not available (or if available, it is not appropriate) for the patient

Exclusion Criteria:

  • Patients requiring treatment with oral etoposide or oral topotecan
  • Patients outside of the United States

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 5, 2020
    Last Updated
    March 17, 2021
    Sponsor
    G1 Therapeutics, Inc.
    Collaborators
    Bionical Emas
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04504513
    Brief Title
    Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer
    Official Title
    Expanded Access Program: Trilaciclib for Chemotherapy-induced Myelosuppression in Patients Receiving Chemotherapy for Small Cell Lung Cancer
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    G1 Therapeutics, Inc.
    Collaborators
    Bionical Emas

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer
    Keywords
    Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Limited Stage, Small Cell Lung Cancer Metastatic, Chemotherapy-induced Neutropenia, Chemotherapy-induced Anemia, CDK 4/6 Inhibitor, trilaciclib, etoposide, carboplatin, cisplatin, topotecan, checkpoint inhibitor, myelosuppression, cyclin-dependent kinase 4/6 inhibitor, myelopreservation, Real World Data, chemotherapy-induced myelosuppression

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Trilaciclib
    Other Intervention Name(s)
    G1T28
    Intervention 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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients who require treatment with either intravenous etoposide + platinum (carboplatin or cisplatin) ± an anti-PDL1 or anti-PD1 checkpoint inhibitor OR intravenous topotecan Pathologically confirmed diagnosis of SCLC Extensive-stage or limited-stage SCLC; patients with limited-stage SCLC receiving chemotherapy with concurrent radiation are NOT eligible. Age ≥ 18 years ECOG 0 to 2 Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L at time of initiation of therapy in this EAP Platelet count ≥ 100 x 10^9/L at time of initiation of therapy in this EAP Glomerular filtration rate (GFR) of ≥ 20 mL/minute at time of initiation of therapy in this EAP Total bilirubin ≤ 1.5x ULN (upper limit normal) at time of initiation of therapy in this EAP AST or ALT ≤ 2.5x ULN (≤ 5x ULN in the presence of liver metastases) at time of initiation of therapy in this EAP QTcF interval ≤ 450 msec (males) or ≤ 470 msec (females) at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF ≤ 500 msec No personal or family history of long QT syndrome Female patient is not lactating or currently pregnant, or plans to become pregnant, while participating in this expanded access program Female patients of reproductive potential agree to use effective contraception while in the program and for at least 3 weeks after the last dose of trilaciclib Patient agrees not to participate in another expanded access program or clinical trial with an experimental treatment during participation in this EAP Active clinical trial with trilaciclib is not available (or if available, it is not appropriate) for the patient Exclusion Criteria: Patients requiring treatment with oral etoposide or oral topotecan Patients outside of the United States

    12. IPD Sharing Statement

    Links:
    URL
    https://www.g1therapeutics.com/patients/access-to-investigational-therapies/
    Description
    G1 Therapeutics policy on expanded access

    Learn more about this trial

    Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

    We'll reach out to this number within 24 hrs