Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

October 31, 2012

Study Completion Date

January 31, 2013

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

ISIS EIF4E Rx

800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle

DRUG

ISIS EIF4E Rx

1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle

DRUG

ISIS EIF4E Rx

(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8, and 15 of each 21 day cycle

DRUG

Paclitaxel

200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle

DRUG

Carboplatin

AUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle

Trial Locations (29)

35216

Achieve Clinical Research, Birmingham

40202

University of Louisville - James Graham Brown Cancer Center, Louisville

40245

Jewish Hospital & St. Mary's Healthcare, Louisville

44718

Gabrail Cancer Center, Canton

60435

Joliet Hematology Oncology Associates, Joliet

71913

Genesis Cancer Center, Hot Springs

72205

Little Rock Cancer Clinic, Little Rock

72703

Highlands Oncology Group, Fayetteville

78229

Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio

90057

Kenmar Research Institute, Los Angeles

129128

Non-State Medical Institution: Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC Russian Railways, Chemotherapy Dept., Moscow

153013

State Healthcare Institution: Ivanovo Regional Oncology Center, Chemotherapy Department, Ivanovo

163045

State Medical Institution: Arkhangelsk Regional Clinical Oncology Center, Chemotherapy department, Arkhangelsk

194291

State Healthcare Institution: Leningrad Regional Clinical Hospital, Thoracic Surgery Department, Saint Petersburg

197022

"St. Petersburg State Healthcare Institution: City Clinical Oncology Center", Saint Petersburg

197101

State Higher Educational Institution: St. Petersburg State Medica University n.a.I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Pulmonology Research Institute, Saint Petersburg

443031

State Institution: Samara Regional Clinical Oncology Center, Chemotherapy Department, Samara

454087

State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Clinical Oncology Center, Chemotherapy Department, Chelyabinsk

620036

State Budget Healthcare Institution: Sverdlovsk Regional Oncology Center, Radiotherapy Department, Yekaterinburg

H-1121

Koranyi National Institute of TBC and Pulmonology, Budapest

H-1125

Semmelweis University Faculty of Medicine, Budapest

H-4032

University of Debrecen, Medical and Health Science Center, Debrecen

H-6772

Hospital for Thoracic Diseases of Csongrad County Local Governmental, Deszk

H-5703

Bekes Country Pandy Kalman Hospital, Gyula

15-540

K. Dluski Provincial Specialist Hospital, Bialystok

20-954

Independent Public Teaching Hospital No. 4 In Lublin, Lublin

10-357

Idependent Public Tuberculosis an Lung Diseases Facilities, Olsztyn

35-241

Specialist Tuberculosis and Lung Diseases Hospitals, Rzeszów

44-300

Alojzy Pawelec Provincial Hospital of Lung Diseases, Wodzisław Śląski

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY