Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-02-29

Brief Summary

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To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC

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Detailed Description

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Conditions

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Oncology Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AMG 954/Panitumumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
* Received only one prior treatment (not including radiation)
* Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
* Life expectancy of ≥ 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal and hepatic function

Exclusion Criteria

* Brain metastases requiring treatment
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
* Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
* Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors
* Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
* Prior therapy with sirolimus, sirolimus analogs
* Immunosuppressive agents within 28 days before enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No