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Colorectal

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy (CORRECT)

Unique Dataset IDColorec_BayerHe_2010_273
DownloadableNo
SponsorBayer HealthCare Pharmaceuticals Inc.Data ProviderBayer HealthCare Pharmaceuticals Inc.Total Study Enrolled Patients760Comparator (Control) Arm Enrolled Patients251RandomizationYesClinicalTrial.gov IDNCT01103323ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT01103323
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrug, PlaceboDataset TypeOther

Clinical Trial Title

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy (CORRECT)

Trial Summary and Conditions

This study was conducted to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. Regorafenib (Stivarga, BAY73-4506) was given at160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Best Supportive Care (BSC) includes any concomitant medications or treatments except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.

Data Summary

SAS data sets representing control arm patients including raw data on safety, efficacy, demographics, in 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 efficacy endpoint of this study is Overall survival o The secondary efficacy endpoints of this study are: Progression free survival; Objective tumor response rate; Disease control rate o The tertiary endpoints of this study are: Duration of response and stable disease; Health Related Quality of Life; Pharmacokinetics of regorafenib; Biomarker evaluation

Outcome Measures

Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented. The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis. For more details, please see study protocol.

Available Downloads:

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

PROTOCOL: Protocol 14387 CORRECT redacted.pdf

CRF: BAY 73-4506_14387_all visits.pdf

DATA DICTIONARY: pds_oad_specifications_v1.0.xls

DATA (COMPARATOR ARM): datasets.zip