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Type(s) of Cancer
Lung
Study Phase
Phase 2B
Study Completion Date
2017-07-03
NCT02499770Uploaded 11-05-2020
Available for Download
PDS UID: LungSm_G1Thera_2015_433
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin
Provider Information
Provider Data DescriptionPrimary (control portion of the study): Assess the safety and tolerability of G1T28 administered with E/P therapy Secondary (control portion of the study): Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with E/P therapy; Assess the incidence of febrile neutropenia; Assess the incidence of infections; Assess the utilization of RBC and platelet transfusions; Assess the utilization of hematopoietic growth factors ; Assess the utilization of systemic antibiotics; Assess the incidence of chemotherapy dose reductions and dose interruptions overall; Assess the incidence of Grade 2 or greater nephrotoxicity ; Assess tumor response based on RECIST, Version 1.1; Assess PFS and overall survival ***Complete list can be found in the NCT listing.
SponsorG1 Therapeutics, Inc.
Data ProviderG1 Therapeutics, Inc.
Partial set or SubsetOriginal Data
Patients in dataset77
# of Patients Control38
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/gt37-js55
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: Carboplatin
Drug: Placebo
Drug: Trilaciclib
Drug: Etoposide
Drug(s)Drug: Carboplatin
Drug: Trilaciclib
Drug: Etoposide
Drug: Placebo
Total Enrolled122
RandomizationRandomized
Blinding MethodDouble
Arms Interventiontrilaciclib + carboplatin/etoposide - Experimental
trilaciclib/placebo + carboplatin/etoposide - Experimental
Secondary ID2016-001583-11
PubMed (PMID)34408488
34405547
33595690
33004541
31504118
Collaborator(s)N/A
Region(s)United States
France
Georgia
Hungary
Moldova, Republic of
Poland
Spain
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLNot Provided
CRFNot Provided
DATA DICTIONARYData descriptors for SCLC 01.xlsx
DATA SUMMARYDescriptive_Stats_G1T_NCT02499770.xlsx
DATA SUMMARYProc Contents Data Dictionary G1T_NCT02499770.pdf
DATA (COMPARATOR ARM)addv.sas7bdat
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DATA (COMPARATOR ARM)adex2.sas7bdat
DATA (COMPARATOR ARM)adae.sas7bdat
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DATA (COMPARATOR ARM)adtr2.sas7bdat
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DATA (COMPARATOR ARM)adtr.sas7bdat
DATA (COMPARATOR ARM)advs.sas7bdat
DATA (COMPARATOR ARM)adlb.sas7bdat
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