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Lung (Small Cell)

Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy

Unique Dataset IDLungSm_G1Thera_2015_434ClinicalTrial.gov IDNCT02514447
DownloadableYes
SponsorG1 Therapeutics, Inc.Data ProviderG1 Therapeutics, Inc.Total Study Enrolled Patients91Comparator (Control) Arm Enrolled Patients29RandomizationYes
Study PhaseClinical Study Phase IIBBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyDataset TypeADS

Clinical Trial Title

Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy

Trial Summary and Conditions

This 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 topotecan in patients previously treated for 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. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.

Data Summary

Control arm data on demographics, safety, efficacy (ORR, PFS, OS), treatment exposure, concomitant medications, medical history, ECOG performance status, prior/concomitant procedures, and labs

Study Objectives

Primary (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

Outcome Measures

Primary (Control portion of the study): Duration of Severe (Grade 4) Neutropenia in Cycle 1; Occurrence of Severe (Grade 4) Neutropenia Key Secondary (Control portion of the study): Major Adverse Hematologic Events (MAHE); Occurrence of Red Blood Cell Transfusions on/After Week 5; Occurrence of G-CSF Administrations; Occurrence of Platelet Transfusions; Occurrence of All-Cause Chemotherapy Dose Reductions; Overall survival

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Dummy.txt

CRF: Blank.txt

DATA DICTIONARY: Data descriptors for SCLC 02.xlsx

DATA SUMMARY: Proc Contents Data Dictionary G1T_NCT02514447.pdf

DATA SUMMARY: Descriptive_Stats_G1T_NCT02514447.xlsx

DATA (COMPARATOR ARM): addv.sas7bdat

DATA (COMPARATOR ARM): adecog.sas7bdat

DATA (COMPARATOR ARM): adex2.sas7bdat

DATA (COMPARATOR ARM): adae.sas7bdat

DATA (COMPARATOR ARM): adex.sas7bdat

DATA (COMPARATOR ARM): adeg.sas7bdat

DATA (COMPARATOR ARM): admh.sas7bdat

DATA (COMPARATOR ARM): adpr.sas7bdat

DATA (COMPARATOR ARM): adsl.sas7bdat

DATA (COMPARATOR ARM): adcm.sas7bdat

DATA (COMPARATOR ARM): adrs.sas7bdat

DATA (COMPARATOR ARM): adtte.sas7bdat

DATA (COMPARATOR ARM): adtr2.sas7bdat

DATA (COMPARATOR ARM): adtr.sas7bdat

DATA (COMPARATOR ARM): advs.sas7bdat