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Lung (Small Cell)

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

Unique Dataset IDLungSm_G1Thera_2015_433ClinicalTrial.gov IDNCT02499770
DownloadableYes
SponsorG1 Therapeutics, Inc.Data ProviderG1 Therapeutics, Inc.Total Study Enrolled Patients77Comparator (Control) Arm Enrolled Patients38RandomizationYes
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 Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin

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 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.

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 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.

Outcome Measures

Primary (control portion of the study) : Duration of Severe (Grade 4) Neutropenia Secondary (control portion of the study) : Occurrence of Severe (Grade 4) Neutropenia ; Occurrence of Febrile Neutropenia ; Duration of Grade 3/4 Neutropenia ; Occurrence of Grade 3/4 Neutropenia; Nadir of Absolute Neutrophil Count in Cycle 1; Occurrence of G-CSF Administration; Occurrence of RBC Transfusion ; Change from Baseline of Hemoglobin at the End of Cycle 6 ; Occurrence of ESA Administration ; Occurrence of Platelet Transfusion ; Change from Baseline of Platelet Count at the End of Cycle 6 ; Change from Baseline of Lymphocyte Count at the End of Cycle 6 ; Occurrence of Dose Reduction; Occurrence of Infectious SAEs ; Occurrence of Pulmonary Infection SAE; Occurrence of IV Antibiotic Administration ; Time to First MAHE; Best Overall Tumor Response Based on Assessments; Best Overall Tumor Response Based on BICR Assessments; PFS Based on Assessments; OS

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 01.xlsx

DATA SUMMARY: Descriptive_Stats_G1T_NCT02499770.xlsx

DATA SUMMARY: Proc 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