15
Participants
Start Date
January 31, 2009
Primary Completion Date
August 31, 2010
Study Completion Date
August 31, 2010
AMG 479
AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1
AMG 479
AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1
Carboplatin
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
AMG 479
AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1
Paclitaxel
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Research Site, Bethlehem
Research Site, Winston-Salem
Research Site, Greenville
Research Site, Memphis
Research Site, Paducah
Research Site, Indianapolis
Research Site, Indianapolis
Research Site, Fort Wayne
Research Site, New Albany
Research Site, Lafayette
Research Site, Madison
Research Site, Fayetteville
Research Site, Fayetteville
Research Site, Fort Wayne
Research Site, Indianapolis
Research Site, Lafayette
Research Site, New Albany
Research Site, Paducah
Research Site, St Louis
Research Site, Winston-Salem
Research Site, Bethlehem
Research Site, Greenville
Research Site, Memphis
Research Site, Madison
Research Site, St Louis
Lead Sponsor
NantCell, Inc.
INDUSTRY