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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00352950
• Other study ID #: 20040145
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Oncology

Intervention

Drug:
• AMG 954/Panitumumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety within the first 3 weeks
Secondary	pharmacodynamic analysis of mTOR

External Links

•   AmgenTrials clinical trials website