Expired Study
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Las Vegas, Nevada


Purpose:

This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.


Criteria:

Inclusion Criteria (include but are not limited to): - Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC. - Measurable or evaluable disease as defined by RECIST - Must have failed at least one prior chemotherapy regimen or have refused chemotherapy. - ECOG perfromance status of 0,1, or 2. Exclusion Criteria (include but are not limited to): - Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier. - Evidence of New York Heart Associatation Class III or greater cardiac disease. - History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months. - Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin. - Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week. - Pregnant or nursing women. - Patients who are primarily refactory to erlotinib.


NCT ID:

NCT00569114


Primary Contact:

Study Director
Sara Zaknoen, MD
Tragara Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Las Vegas, Nevada
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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