Jonsson Comprehensive Cancer Center
This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung adenocarcinoma. Dapagliflozin is approved by the Food and Drug Administration (FDA) for the treatment of diabetes and heart failure. It is an SGLT2 inhibitor. Stage I lung adenocarcinomas express significantly higher levels of the SGLT2 protein than other stages, and research suggests that SGLT2 inhibition improves lung cancer outcomes in patients with diabetes. In this study, dapagliflozin is being used off-label, which means it is being used for a condition that it was not originally approved for by the FDA. The investigational study drug is a neoadjuvant treatment, meaning the drug is given before surgery to try and help make the surgery more effective.
PRIMARY OBJECTIVE: I. To assess safety and tolerability of administering 30 days of neoadjuvant dapagliflozin propanediol (dapagliflozin) before surgery in subjects with stage Ia lung adenocarcinoma. SECONDARY OBJECTIVE: I. To measure the effects of dapagliflozin on tumor cell proliferation in lung adenocarcinoma. EXPLORATORY OBJECTIVES: I. To measure the effects of neoadjuvant dapagliflozin on biological and metabolic parameters. II. To measure the effects of neoadjuvant dapagliflozin on biomarkers. OUTLINE: Patients receive dapagliflozin orally (PO) once daily (QD) for 30 days in the…
Inclusion Criteria: * Must be able to provide written informed consent * Male or female ≥ 22 years of age at visit 1 * Histologically confirmed stage Ia lung adenocarcinoma, with availability of biopsy tissue for Ki-67 determination * Planning to undergo surgery for lung adenocarcinoma * Willing and able to receive a research CT-guided lung biopsy * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Leukocytes ≥ 3.0 K/mm\^3 * Absolute neutrophil count ≥ 1.5 K/mm\^3 * Platelets ≥ 100 K/mm\^3 * Total bilirubin ≤ 2 mg/dl * Aspartate aminotransferase (AST) ≤ 62 IU/L * Alanine amin…
Undergo collection of blood and urine samples
Undergo CT-guided biopsy
Given PO
Ancillary studies
Arctuva estimate
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