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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00352950

Enrollment

Registered

2006-07-17

Start date

2006-03-31

Completion date

2008-02-29

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer, Oncology

Keywords

NSCLC, Lung cancer, Panitumumab, Sirolimus, mTOR, Monoclonal antibody

Brief summary

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

Interventions

DRUGAMG 954/Panitumumab

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
safety within the first 3 weeks	—

Secondary

Measure	Time frame
pharmacodynamic analysis of mTOR	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026