AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Solid TumorsAdvanced Cancer
Interventions
DRUG

AMG 531

"Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose).~1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)"

DRUG

Carboplatin

AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.

DRUG

Adriamycin

75-90 mg/m\^2 IV

DRUG

Ifosfamide

10 gm/m\^2 IV; OR, High dose ifosfamide = 14 gm/m\^2.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER