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
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
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
NCT ID
NCT04504513
First Posted
August 5, 2020
Last Updated
March 17, 2021
Sponsor
G1 Therapeutics, Inc.
Collaborators
Bionical Emas
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
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Primary Completion Date
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Study Completion Date
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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
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