RecruitingEarly phase 1interventionalRules rewrite

Early phase 1: testing Dapagliflozin Propanediol for Lung Adenocarcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT07235280 · Jonsson Comprehensive Cancer Center · enrollment listed as 48

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography Assisted Biopsy, or Dapagliflozin Propanediol. The registry lists allocation as na. This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung adenocarcinoma.

They plan to enroll about 48 people at Los Angeles. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma

Interventions: Biospecimen Collection, Computed Tomography Assisted Biopsy, Dapagliflozin Propanediol, Questionnaire Administration

Primary outcome (registry wording): Incidence of adverse events

Who it is for (from inclusion criteria)

Ages 22 Years to any
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

Who the registry excludes

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 with the protocol requirements or complete the study
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 carcinoma
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 allowed
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin

Public study contact (from the registry)

Amanda R. Gonzalez

310-794-4376

rngonzalez@mednet.ucla.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California (recruiting)

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FAQ about this NCT record

Is NCT07235280 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07235280?

Early phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07235280?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary