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Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer
This study has been withdrawn prior to recruitment.
First Received: April 6, 2006   Last Updated: December 20, 2007   History of Changes
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00352950
  Purpose

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


Condition Intervention Phase
Oncology
Non-Small Cell Lung Cancer
Drug: AMG 954/Panitumumab
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • safety within the first 3 weeks

Secondary Outcome Measures:
  • pharmacodynamic analysis of mTOR

Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: February 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352950

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20040145
Study First Received: April 6, 2006
Last Updated: December 20, 2007
ClinicalTrials.gov Identifier: NCT00352950     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
NSCLC, Lung cancer
Panitumumab
Sirolimus
mTOR
Monoclonal antibody

Study placed in the following topic categories:
Thoracic Neoplasms
Sirolimus
Anti-Infective Agents
Immunologic Factors
Immunosuppressive Agents
Carcinoma
Antibodies, Monoclonal
Anti-Bacterial Agents
Antibodies
Respiratory Tract Diseases
Lung Neoplasms
Antifungal Agents
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Immunoglobulins

Additional relevant MeSH terms:
Thoracic Neoplasms
Sirolimus
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Antifungal Agents
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009