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Type(s) of Cancer
Lung
Study Phase
Phase 2B
Study Completion Date
2018-09-28
NCT02514447Uploaded 11-05-2020
Available for Download
PDS UID: LungSm_G1Thera_2015_434
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 Information
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
DOIhttps://doi.org/10.34949/z3wz-rx52
CDISC StandardADS
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.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: Trilaciclib
Drug: Placebo
Drug: Topotecan
Drug(s)Drug: Placebo
Drug: Topotecan
Drug: Trilaciclib
Total Enrolled123
RandomizationRandomized
Blinding MethodDouble
Arms InterventionPlacebo + Topotecan 1.5 mg/mē - Parts 2a and 2b - Experimental
Trilaciclib (G1T28) 240 mg/mē + Topotecan 0.75 mg/mē - Part 2a - Experimental
Trilaciclib (G1T28) 240 mg/mē + Topotecan 1.5 mg/mē - Part 2b - Experimental
Trilaciclib (G1T28) 200 mg/mē + Topotecan 1.5 mg/mē - Cohort 1- Part 1 - Experimental
Trilaciclib (G1T28) 200 mg/mē + Topotecan 1.25 mg/mē - Cohort 2- Part 1 - Experimental
Trilaciclib (G1T28) 200 mg/mē + Topotecan 0.75 mg/mē - Cohort 3- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/mē + Topotecan 0.75 mg/mē - Cohorts 4 and 6- Part 1 - Experimental
Trilaciclib (G1T28) 280 mg/mē + Topotecan 0.75 mg/mē - Cohort 5- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/mē + Topotecan 1.0 mg/mē - Cohort 7- Part 1 - Experimental
Secondary ID2016-004611-13
PubMed (PMID)33123968
35842567
34408488
34405547
33595690
Collaborator(s)N/A
Region(s)United States
Belgium
Bosnia and Herzegovina
Croatia
North Macedonia
Serbia
Slovakia
Slovenia
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLNot Provided
CRFNot Provided
DATA DICTIONARYData descriptors for SCLC 02.xlsx
DATA SUMMARYProc Contents Data Dictionary G1T_NCT02514447.pdf
DATA SUMMARYDescriptive_Stats_G1T_NCT02514447.xlsx
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DATA (COMPARATOR ARM)adecog.sas7bdat
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DATA (COMPARATOR ARM)adtr2.sas7bdat
DATA (COMPARATOR ARM)adtr.sas7bdat
DATA (COMPARATOR ARM)advs.sas7bdat
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