A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
NeoplasmsNeoplasms, OvarianNeoplasms, BreastAdvanced or Refractory Solid Malignancies
Interventions
DRUG

DOXIL/CAELYX (doxorubicin) Treatment Sequence AB

Cycle 1 = Treatment A, Cycle 2 = Treatment B

DRUG

DOXIL/CAELYX (doxorubicin) Treatment Sequence BA

Cycle 1 = Treatment B, Cycle 2 = Treatment A

Trial Locations (8)

Unknown

Nashville

San Antonio

Brussels

Wilrijk

Barcelona

Madrid

Valencia

London

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01815294 - A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer | Biotech Hunter | Biotech Hunter