Expanded Access to Trilaciclib for Patients Receiving Che... | NCT04504513

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

NCT04504513

Sponsor

G1 Therapeutics, Inc.

Status

Approved for marketing

Last Update Posted

Mar 19, 2021Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Myelosuppression Adult
Chemotherapeutic Toxicity
Small Cell Lung Cancer

Interventions

Trilaciclib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 5, 2020

First Submission Date that Met QC Criteria

Aug 5, 2020

First Posted Date

Aug 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2021

Last Update Posted Date

Mar 19, 2021Actual

Name	Class
Bionical Emas	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Treatment IND/Protocol

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trilaciclib	Drug	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.		G1T28

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D055752	Small Cell Lung Carcinoma
D008175	Lung Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms