To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action. This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm. To view information about this, please visit the FAQ. If you have any further questions, please contact us.
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
Provider Data DescriptionPrimary (control portion of the study): Assess the safety and tolerability of G1T28 administered with topotecan
Key secondary (control portion of the study): Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with topotecan; Assess the utilization of RBC and platelet transfusions; Assess the utilization of hematopoietic growth factors; Assess the incidence of chemotherapy dose reductions and dose interruptions overall; Assess PFS and overall survival
SponsorG1 Therapeutics, Inc.
Data ProviderG1 Therapeutics, Inc.
Partial set or SubsetOriginal Data
Patients in dataset91
# of Patients Control29
# of Patients ExperimentalN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC.
The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit.