Phase II Study of Dasatinib in Advanced Non-small Cell Lung Cancer With Ex Vivo and In Vivo Assessment of Tumor Target Modulation
Cycle 1 Day 1 (C1D1): Patients will have complete history and physical (H&P), complete blood
count (CBC), complete metabolic panel (CMP) and electrocardiogram (EKG) on day 1. Each cycle
is 28 days. The C1D1 EKG can be omitted if the patient has no new cardiac symptoms and has
not starting taking any medication known to affect QT corrected for heart rate (QTc)
prolongation. Any residual toxicity from prior therapy for cancer will be recorded. Blood
will be drawn for assessment of serum markers. The patient will begin dasatinib at the
starting C1D1 on a daily basis.
Cycle 1 Day 10-20 (C1D10-20): Patients will have a second biopsy to obtain additional tumor
material to examine biological effects of dasatinib on signaling pathways. Dasatinib will be
taken first thing in the morning and the patient will log the time. Blood will also be drawn
for pharmacokinetic assessments of dasatinib levels in plasma and the time recorded. Four
FNA aspirates and 2 core biopsies can be obtained either at the bedside for palpable lesions
or through appropriate image-guided techniques (CT or US) at the discretion of the treating
physician in consultation with radiology. The time of the biopsy will be recorded. One core
biopsy should be immediately fixed in formalin and the other core biopsy should be snap
frozen in liquid nitrogen.
Cycle 2 Day 1 (C2D1): Patients will be seen by the treating physician and have complete H&P,
CBC, and CMP. Blood will be drawn for assessment of serum markers. Toxicity of dasatinib
will be assessed. The patient will continue to take daily doses of dasatinib on a daily
Cycle 2 Day 22 (C2D22): Patients will undergo reevaluation for tumor measurements. This
assessment can occur on C2D22 ±7 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participant Progressors vs. Non-progressors With Tumor Response
We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)
1 year, 4 months
Eric Haura, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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