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Tests treatment safety and results for Lung Adenocarcinoma
Official title Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
ClinicalTrials.gov ID: NCT07235280
What this study is testing
What is Dapagliflozin Propanediol?
Dapagliflozin Propanediol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lung adenocarcinoma.
Also referred to as Dapagliflozin Propylene Glycol Hydrate, Dapagliflozin S-propylene Glycol Monohydrate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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
You likely can't join if
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Women of child-bearing age will receive a urine...
- Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue...
- Current or previous treatment with SGLT2 inhibitors
- History of other malignancies with exception of malignancies for which all treatment was completed at least 2 years before registration with no...
- Currently receiving any other investigational agents
- Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or...
See the full eligibility 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 aminotransferase (ALT) ≤ 70 IU/L
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
- Diabetic status: diabetic people who are not currently receiving treatment will be included in the study. Diabetic people who are under treatment with insulin or oral anti-diabetic drugs will be enrolled under...
- Females of child-bearing potential must have a negative pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must...
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Women of child-bearing age will receive a urine pregnancy test to confirm eligibility
- Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply...
- Current or previous treatment with SGLT2 inhibitors
- History of other malignancies with exception of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell...
- Currently receiving any other investigational agents
- Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is...
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, ketoacidosis, severe kidney disease (estimated glomerular filtration rate [eGFR] \< 30...
- people with HIV are eligible unless their cluster of differentiation 4 (CD4+) T-cell counts are \< 350 cells/µL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.