Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

April 20, 2015

Primary Completion Date

May 15, 2017

Study Completion Date

May 15, 2017

Conditions
Metastatic Small Cell Lung Cancer
Interventions
DRUG

Aldoxorubicin

230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.

DRUG

Topotecan

1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs

Trial Locations (29)

17033

Penn State Hershey Cancer Institute, Hershey

30060

Northwest Georgia Oncology Centers, P.C., Marietta

37203

Sarah Cannon Research Institute, Nashville

37404

Tennessee Oncology, Chattanooga

37909

Tennessee Cancer Specialists, Knoxville

40202

James Graham Brown Cancer Center, Louisville

45242

Oncology Hermatology Care, Inc., Cincinnati

90048

Cedars-Sinai Medical Center, Los Angeles

91030

City of Hope Medical Group, Pasadena

97227

Northwest CCOP Kaiser Permanente, Portland

Unknown

Cancer Specialists of North Florida-Fleming Island, Fleming Island

Koranyi National Institute of TBC and Pulmonologyhhy, Budapest

Koranyi National Institute of TBC and Pulmonology, Budapest

University of Debrecen, Medical and Health Science Center, Department of Pulmonology, Debrecen

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology, Nyíregyháza

Medical Center of the University of Pecs, 1st Department of Internal Medicine, Pécs

Hetenyi Geza Hospital, Szolnok

Hospital General Universitario de Alicante, Alicante

Hospital Clinic i Provincial de Barcelona, Barcelona

Hospital Universitario Quiron-Dexeus (IOR), Barcelona

University Hospital Vall d'Hebron, Barcelona

Hospital Universitario Lucus Augusti, Lugo

General University Hospital Gregorio Maranon, Madrid

Hospital Puerta de Hierro, Madrid

University Hospital Foundation Jimenez Diaz, Madrid

University Hospital La Paz, Madrid

Hospital Regional Universitario, Málaga

University Hospital Virgen de Valme, Seville

CHU Xeral, Vigo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY