Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGTG01
Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD
Sponsors
Tragara Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics. | Baseline, 8, 15 and 28 days |
Countries
United States
Outcome results
None listed