QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Advanced Squamous Non-Small Cell Lung Cancer
Interventions
BIOLOGICAL

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

BIOLOGICAL

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

DRUG

Carboplatin

Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6

BIOLOGICAL

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

DRUG

Paclitaxel

Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6

Trial Locations (25)

18015

Research Site, Bethlehem

27103

Research Site, Winston-Salem

29605

Research Site, Greenville

38120

Research Site, Memphis

42003

Research Site, Paducah

46202

Research Site, Indianapolis

46256

Research Site, Indianapolis

46845

Research Site, Fort Wayne

47150

Research Site, New Albany

47905

Research Site, Lafayette

53792

Research Site, Madison

72703

Research Site, Fayetteville

Unknown

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

63110-1093

Research Site, St Louis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NantCell, Inc.

INDUSTRY