Clinical Trials Logo
  1. Home
  2. Small Cell Lung Cancer
  3. NCT04504513
  4. Details
NCT04504513 Clinical Trial

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

Small Cell Lung Cancer Clinical Trial

Official title:
Expanded Access Program: Trilaciclib for Chemotherapy-induced Myelosuppression in Patients Receiving Chemotherapy for Small Cell Lung Cancer

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04504513
Other study ID # G1T28-501
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date March 2021
Source G1 Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
G1 Therapeutics, Inc. Bionical Emas
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03651219 - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03958045 - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma Phase 2
Completed NCT04381910 - Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04885998 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) Phase 1
Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
Not yet recruiting NCT02875457 - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin Phase 3
Recruiting NCT02605811 - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer Phase 2
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Completed NCT02551432 - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer Phase 2
Withdrawn NCT02542137 - Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT02262897 - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer Phase 2
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Terminated NCT00969306 - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients Phase 1
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A
Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3
Terminated NCT00958022 - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer Phase 1

External Links