Recruiting
Phase 2

Itraconazole

Sponsor:

VA Office of Research and Development

Code:

NCT05563766

Conditions

Esophageal Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Gastroesophageal Junction Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Itraconazole

Study Details

Brief summary:

Esophageal cancer, which has a low 5-year overall survival rate (<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.

Conditions

Esophageal Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Gastroesophageal Junction Carcinoma

Study ID

NCT05563766

Start date

Oct 1, 2024

Status verified date

Nov, 2025

Completion date

Jun 15, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Capable of giving informed consent
  • Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy
  • World Health Organization (WHO)/ECOG performance status (PS) of 0-2 at enrollment
  • Adequate renal and liver function as judged by the treating physician

Exclusion Criteria:

  • Inability to provide Informed Consent
  • NYHA class III or IV CHF
  • LFT>3X upper limit of normal
  • Drug allergy to itraconazole
  • Positive pregnancy test
  • Those with QTc>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant

Study Design

Enrollment

78 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Itraconazole

Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation

Interventions

Itraconazole

Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation

Primary outcome measure

  • Rate of pathological complete response with itraconazole [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

David H Wang, MD PhD

davidh.wang@va.gov

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Albert Lin, MD

650-493-5000albert.lin6@va.gov

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Laura A Randolph, BA

734-845-5091Laura.Randolph@va.gov

Principal Investigator:

David H Wang, MD PhD

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Michael Kelley, MD

919-286-0411michael.kelley6@va.gov

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Kenneth Bensch, MD

503-220-8262kenneth.bensch1@va.gov

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Nicole Pore-Brown

214-857-3291Florine.Pore-Brown@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Yvonne Sada, MD

713-794-7454yvonne.sada@va.gov

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Daniel Wu, MD

206-764-2182daniel.wu@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • Itraconazole
  • Neoadjuvant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-05.