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

Phase 1

Withdrawn

• Conditions: Oncology; Non-Small Cell Lung Cancer

• Registration Number: NCT00352950
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-06
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-17
• Study Completion: 2008-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
safety within the first 3 weeks

Secondary Outcome Measures

Name	Time	Method
pharmacodynamic analysis of mTOR