AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR

PHASE1CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

January 31, 2012

Study Completion Date

June 30, 2015

Conditions
CancerCarcinomaFallopian Tube CancerGynecological MalignanciesMetastasesOncologyOvarian CancerSolid TumorsTumors
Interventions
DRUG

A1: AMG 386 10 mg/kg + Liposomal doxorubicin

Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW

DRUG

A3: AMG 386 15mg/kg + Liposomal doxorubicin

A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W

DRUG

B1: AMG 386 10 mg/kg + Topotecan

B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule

DRUG

B3: AMG 386 15mg/kg + Topotecan

AMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule

Trial Locations (16)

2610

Research Site, Wilrijk

3000

Research Site, Leuven

3011

Research Site, Footscray

3050

Research Site, Parkville

4000

Research Site, Liège

Research Site, Liège

5000

Research Site, Adelaide

19111

Research Site, Philadelphia

27103

Research Site, Winston-Salem

32806

Research Site, Orlando

33612

Research Site, Tampa

43219

Research Site, Columbus

55426

Research Site, Saint Louis Park

58501

Research Site, Bismarck

95817

Research Site, Sacramento

85724-5024

Research Site, Tucson

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00770536 - AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR | Biotech Hunter | Biotech Hunter