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Lung (Small Cell)

A randomized, double blind, placebo-controlled, multicenter phase II study to evaluate efficacy and safety of roniciclib in subjects with extensive-stage disease small cell lung cancer (SCLC) who are receiving cisplatin + etoposide or carboplatin + etoposide as first-line therapy

Unique Dataset IDLungSm_BayerAG_2014_302ClinicalTrial.gov IDNCT02161419
DownloadableNo
SponsorBayer AGData ProviderBayer AGTotal Study Enrolled Patients142Comparator (Control) Arm Enrolled Patients50RandomizationYes
Study PhaseClinical Study Phase IIBBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrug, PlaceboDataset TypeOther

Clinical Trial Title

A randomized, double blind, placebo-controlled, multicenter phase II study to evaluate efficacy and safety of roniciclib in subjects with extensive-stage disease small cell lung cancer (SCLC) who are receiving cisplatin + etoposide or carboplatin + etoposide as first-line therapy

Trial Summary and Conditions

This study was conducted in centers in Europe, North America, and Asia. Subjects received roniciclib or placebo in addition to background chemotherapy of either cisplatin + etoposide or carboplatin + etoposide for 6 cycles and continued thereafter with roniciclib / placebo monotherapy. Subjects were stratified at randomization according to gender (female / male) and serum lactate dehydrogenase (LDH<=2.5 x upper limit of normal [ULN] / >2.5 x ULN). Study treatment continued until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study at the discretion of the investigator or his/her designated associate(s) occurs.

Data Summary

SAS data sets representing control arm patients including raw data on safety, efficacy, demographics, with Bayer legacy data standard. Some data sets have been modified or eliminated in accordance with Bayer Anonymization procedures prior to release to Project Data Sphere.

Study Objectives

o The primary objective was to compare roniciclib with placebo in addition to background treatment with chemotherapy (either cisplatin + etoposide or carboplatin + etoposide) in terms of progression free survival (PFS) in SCLC patients. o Additional efficacy parameters were assessed as secondary objectives (overall survival, time to progression, objective response rate) o Additional objectives of this study were to assess: o Safety o Patient reported outcomes (PROs) o Pharmacokinetics o Biomarker profile

Outcome Measures

Primary outcome measure: progression free survival, Secondary outcome measures: overall survival, time to progression, overall response rate

Available Downloads:

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

PROTOCOL: 14615_redacted_protocol.pdf

CRF: 14615_annotated_ecrf.pdf

DATA DICTIONARY: 14615_pds_oad_specifications_v1.0.xls

DATA (COMPARATOR ARM): 14615_anonymized_data.zip