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An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Oncology, Non-Small Cell Lung Cancer

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Trial Information

An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

safety within the first 3 weeks

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040145

NCT ID:

NCT00352950

Start Date:

March 2006

Completion Date:

February 2008

Related Keywords:

  • Oncology
  • Non-Small Cell Lung Cancer
  • NSCLC, Lung cancer
  • Panitumumab
  • Sirolimus
  • mTOR
  • Monoclonal antibody
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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