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Terminated/Withdrawn
Sponsor ID
20080257

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

Sponsor ID
20080257
Clinicaltrials.gov ID
NCT00807612
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 479
Type
Interventional
Masking
None (Open Label)
Enrollment
49
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Part 1 Only

Part 2: Objective Response Rate as per modified RECIST criteria by investigator review

Timeframe: Length of Study

Secondary Outcome Measures

Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities

Timeframe: Length of Study

Part 1: Incidence of anti-AMG 479 antibody formation

Timeframe: Length of Study

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

Timeframe: Length of Study

Part 2 Incidence of adverse events and laboratory abnormalities

Timeframe: Length of Study

Incidence of anti-AMG479 antibody formation

Timeframe: Length of Study

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Fayetteville, Arkansas, United States
Status
Completed
Location
Research Site
Indianaplolis, Indiana, United States
Status
Completed
Location
Research Site
Fort Wayne, Indiana, United States
Status
Completed
Location
Research Site
New Albany, Indiana, United States
Status
Completed
Location
Research Site
Lafayette, Indiana, United States
Status
Completed
Location
Research Site
Indianapolis, Indiana, United States
Status
Completed
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Study Info
Age
18+ years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Jan 2009 - Aug 2010
    Inclusion and Exclusion Criteria
    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