An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma
Summary
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.
Detailed description
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 absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT)-guided biopsy on study and collection of blood and urine samples throughout the study. After completion of study treatment, patients are followed up between days 64 and 72.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood and urine samples
- ProcedureComputed Tomography Assisted Biopsy
Undergo CT-guided biopsy
- DrugDapagliflozin Propanediol
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Incidence of adverse events
Will be measured by frequency and severity of toxicities related to dapagliflozin per Common Terminology Criteria for Adverse Events version 6.0. Data will be summarized. Adverse events, severe adverse events, and adverse drug reactions will be coded by body system and Medical Dictionary for Regulatory Activities classification term. Adverse events will be tabulated and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
Time frame: Up to day 64-72
Secondary
Tumor cell proliferation change
Time frame: From biopsy to surgery up to day 64-72
Eligibility criteria
Study locations (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095