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

This study has been terminated.
(Based upon data from a similar NSCLC study, it was decided to permanently discontinue enrollment in the 20080257 study.)
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00807612
First received: December 11, 2008
Last updated: August 4, 2011
Last verified: August 2011

December 11, 2008
August 4, 2011
January 2009
August 2010   (final data collection date for primary outcome measure)
  • Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities [ Time Frame: Part 1 Only ] [ Designated as safety issue: Yes ]
  • Part 2: Objective Response Rate as per modified RECIST criteria by investigator review [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00807612 on ClinicalTrials.gov Archive Site
  • Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
  • Part 1: Incidence of anti-AMG 479 antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
  • Part 2: Progression Free Survival, Time to Progression, Duration of Response, 1 & 2 year survival rates, and Overall Survival including subjects who received the final dose in Part 1 [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
  • Part 2 Incidence of adverse events and laboratory abnormalities [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
  • Incidence of anti-AMG479 antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
A Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Squamous Non-Small Cell Lung Cancer
  • 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
  • Experimental: Part 1 Cohort 1
    AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1
    Interventions:
    • Biological: AMG 479
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Part 1 Cohort 2
    AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1
    Interventions:
    • Biological: AMG 479
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Part 2

    AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1

    (AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)

    Interventions:
    • Drug: Carboplatin
    • Biological: AMG 479
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced squamous NSCLC
  • Measurable disease as defined per modified RECIST criteria
  • ECOG performance status of 0 or 1
  • ≥18 years old
  • Adequate glycemic function, for subjects with known diabetes

Exclusion Criteria:

  • Untreated or symptomatic central nervous system (CNS) metastases
  • Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00807612
20080257
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP