Status:
WITHDRAWN
Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Amgen
Conditions:
Oncology
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00352950
Start Date
March 1 2006
End Date
February 1 2008
Last Update
September 6 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.