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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
October 2009
NCT00540514Uploaded 11-08-2014
Available for Download
PDS UID: LungNo_Celgene_2007_108
A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Provider Information
Provider Data DescriptionTo evaluate the safety and efficacy of 100 mg/m2 30-minute infusion of nab-paclitaxel on days 1, 8, and 15 followed by carboplatinAUC6mg/mL/min(per Calvert formula)19 on day 1 every 3 weeks (nab-PC) compared with 200 mg/m2 3-hour infusion of sb-paclitaxel plus carboplatin at AUC 6 (sb-PC), both given every 3 weeks, as first-line therapy in patients with advanced NSCLC
SponsorCelgene Corporation
Data ProviderCelgene
Partial set or SubsetOriginal Data
Patients in dataset1052
# of Patients Control524
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/frxt-tf98
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
ConditionsNon-Small Cell Lung Carcinoma
Intervention TypeDrug: Albumin-bound paclitaxel
Drug: Paclitaxel
Drug: Carboplatin
Drug(s)Drug: Albumin-bound paclitaxel
Drug: Carboplatin
Drug: Paclitaxel
Total Enrolled1052
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionAlbumin-bound paclitaxel + Carboplatin - Experimental
Paclitaxel + Carboplatin - Active Comparator
Secondary IDN/A
PubMed (PMID)24467217
25572008
26035702
22547591
23123509
23545279
23842283
24346096
Collaborator(s)N/A
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLCA031 NSCLC Protocol.pdf
CRFCA031 NSCLC CRF.pdf
DATA DICTIONARYPDS_Data_Profile_Created_108.xlsx
DATA (COMPARATOR ARM)CA031 NCSLC Data Files.zip
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