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Type(s) of Cancer
Lung
Study Phase
Phase 2B
Study Completion Date
2015
NCT02499770Uploaded 11-05-2020
Available for Download
PDS UID: LungSm_G1Thera_2015_433
N/A
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 SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
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
DATA (COMPARATOR ARM)adeg.sas7bdat
DATA (COMPARATOR ARM)adex2.sas7bdat
DATA (COMPARATOR ARM)adae.sas7bdat
DATA (COMPARATOR ARM)adex.sas7bdat
DATA (COMPARATOR ARM)adcm.sas7bdat
DATA (COMPARATOR ARM)adqs.sas7bdat
DATA (COMPARATOR ARM)admh.sas7bdat
DATA (COMPARATOR ARM)adpr.sas7bdat
DATA (COMPARATOR ARM)adsl.sas7bdat
DATA (COMPARATOR ARM)adtr2.sas7bdat
DATA (COMPARATOR ARM)adtte.sas7bdat
DATA (COMPARATOR ARM)adrs.sas7bdat
DATA (COMPARATOR ARM)adtr.sas7bdat
DATA (COMPARATOR ARM)advs.sas7bdat
DATA (COMPARATOR ARM)adlb.sas7bdat
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