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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
January 2007
NCT00119613Uploaded 08-03-2018
Available for Download
PDS UID: LungSm_Amgen_2002_266
A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
Provider Information
Provider Data DescriptionPrimary Objective - To evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive stage small cell lung cancer (SCLC), increases survival. Secondary Objective - To evaluate whether darbepoetin alfa improves FACT-Fatigue subscale scores. Safety Objective - To assess the safety profile of darbepoetin alfa in subjects with previously untreated extensive stage SCLC. Study Design - Randomized, double-blind, placebo controlled, multicenter study. Eligible subjects will be randomized in a 1:1 ratio to treatment with darbepoetin alfa or placebo and will be stratified by region, ECOG performance status, and LDH level. Subjects will receive study drug (darbepoetin alfa or placebo) throughout the 6 cycles of chemotherapy and for 3 weeks after the last dose of chemotherapy. Subjects will be followed until death, or at the point at which all randomized subjects have completed their end of study treatment visit and 496 deaths have occurred. This will be the End of Study. Long term follow-up will run from the end of study until all subjects have died. Sample size - The planned sample size is approximately 600 subjects randomized in a 1:1 ratio Primary Endpoints - 1) change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period 2) survival time Secondary endpoints - 1) change to FACT-Fatigue subscale scores from baseline to the end of study treatment Safety Endpoints - 1) incidence of adverse events (including serious and treatment related), changes in laboratory values, changes in vital signs and incidence of concomitant medications.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset600
# of Patients Control301
# of Patients Experimental299
DOIhttps://doi.org/10.34949/shvm-xw45
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: placebo
Drug: darbepoetin alfa
Drug(s)Drug: darbepoetin alfa
Drug: placebo
Total Enrolled600
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionGroup 1 - darbepoetin alfa - Experimental
Group 2 - Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)18467726
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOL20010145_01.20.01 Protocol Amend 2 2004-07-16 English_Redacted.pdf
CRFAmgen 20010145 DDT - v2.pdf
DATA DICTIONARYAmgen 20010145 DDT.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)SAS dataset - 20010145.zip
OTHERAmgen 20010145 CRF PRO.pdf
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