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

Primary Purpose

Oncology, Non-Small Cell Lung Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 954/Panitumumab
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncology focused on measuring NSCLC, Lung cancer, Panitumumab, Sirolimus, mTOR, Monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    safety within the first 3 weeks

    Secondary Outcome Measures

    pharmacodynamic analysis of mTOR

    Full Information

    First Posted
    April 6, 2006
    Last Updated
    September 4, 2018
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00352950
    Brief Title
    Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer
    Official Title
    An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2008 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oncology, Non-Small Cell Lung Cancer
    Keywords
    NSCLC, Lung cancer, Panitumumab, Sirolimus, mTOR, Monoclonal antibody

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    AMG 954/Panitumumab
    Primary Outcome Measure Information:
    Title
    safety within the first 3 weeks
    Secondary Outcome Measure Information:
    Title
    pharmacodynamic analysis of mTOR

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

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

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