Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

January 31, 2012

Study Completion Date

August 31, 2012

Conditions
Metastatic Non-small Cell Lung Cancer
Interventions
DRUG

CS7017 tablets

CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months

DRUG

Paclitaxel

Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks

DRUG

Carboplatin

IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks

DRUG

Placebo Tablets

Placebo tablets matching CS-7017 tablets

Trial Locations (28)

17033

Penn State Milton Hershey Cancer Center, Hershey

20007

Georgetown Univ. Medical Center, Washington D.C.

21225

Harbor View Cancer Center, Baltimore

23507

Eastern Virginia Medical School, Norfolk

45042

Southern Illinois Hematology/Oncology, Centralia

46601

Michiana Hematology-Oncology, South Bend

60612

Rush University Medical Center, Chicago

62801

Signal Point Clinical Research Center, Middletown

80045

University Colorado Cancer Center, Aurora

300239

Oncomed SRL, Timișoara

380009

Hemato-Oncology Clinic, Vedanta, Gujarat

400015

Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

411007

Pentagon Research, Aundh

422005

Shatabdi Super Specialty Hospital, Nashik

560029

Kidwai Memorial Institute of Oncology, Bangalore

600035

Apollo Specialty Hospital, Chennai

700054

Orchid Nursing Home, Kolkata

02114

Massachusetts General Hospital, Boston

625 107

Meenakshi Mission Hospital, Madurai

411 001

Ruby Hall Clinic, Pune

411 013

Noble Hospital, Pune

10-228

Oddzial Chemioterapii ZOZ MSWiA, Olsztyn

60-569

Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii, Poznan

70-891

Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego, Szczecin

Unknown

Spitalul Municipal Ploiesti, Ploieşti

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu, Bucharest

Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

Centrul de Oncologie Medicala, Iași

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT00806286 - Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter