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

NCT04504513 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2021-03-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trilaciclib

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.

Sponsors & Collaborators

  • Bionical Emas

    collaborator INDUSTRY

  • G1 Therapeutics, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04504513 on ClinicalTrials.gov