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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Squamous Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities

Outcome Time Frame:

Part 1 Only

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20080257

NCT ID:

NCT00807612

Start Date:

January 2009

Completion Date:

August 2010

Related Keywords:

  • Advanced Squamous Non-Small Cell Lung Cancer
  • AMG 479
  • IGF-1R
  • Apoptosis
  • Monoclonal Antibody
  • Advanced Squamous Non-Small Cell Lung Cancer
  • antibody 1st-line
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteBentonville, Arkansas  
Research SiteBloomington, Indiana  
Research SiteAshland, Kentucky  
Research SiteBranson, Missouri  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAppleton, Wisconsin