NCT04018872

Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

Recruiting now Phase 2 Last updated 4 November 2021

What this trial tests

Phase 2 trial testing Itraconazole in Esophagus Adenocarcinoma in 78 participants. Currently enrolling.

Timeline

24 June 2019

Primary endpoint
24 June 2026

29 September 2026

Quick facts

Lead sponsor	Dallas VA Medical Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	24 June 2019
Primary completion	24 June 2026
Estimated completion	29 September 2026
Sites	1 location across United States

Drugs / interventions tested

• Itraconazole — full drug profile →

Conditions studied

• Esophagus Adenocarcinoma — all drugs for Esophagus Adenocarcinoma →
• Esophagus Squamous Cell Carcinoma — all drugs for Esophagus Squamous Cell Carcinoma →
• Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

Dallas VA Medical Center

Who can join

18 and older, any sex, with Esophagus Adenocarcinoma or Esophagus Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Esophageal cancer, which has a low 5-year overall survival rate for all stages (\<20%) , is increasing in incidence. Previous studies have shown that the Hedgehog (Hh) and AKT signaling pathways are activated in a significant proportion of esophageal cancers. Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT. In this phase II clinical trial, the investigators aim to evaluate the effect of itraconazole as a neoadjuvant therapy following standard of care chemoradiation in the treatment of locoregional esophageal and gastroesophageal junction carcinomas.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characteristics of the cancer stem cell niche and therapeutic strategies.
   Ju F, Atyah MM, Horstmann N, Gul S, et al · · 2022 · cited 84× · PMID 35659296 · DOI 10.1186/s13287-022-02904-1
2. New drugs are not enough‑drug repositioning in oncology: An update.
   Armando RG, Mengual Gómez DL, Gomez DE. · · 2020 · cited 72× · PMID 32124955 · DOI 10.3892/ijo.2020.4966
3. Itraconazole Exerts Its Antitumor Effect in Esophageal Cancer By Suppressing the HER2/AKT Signaling Pathway.
   Zhang W, Bhagwath AS, Ramzan Z, Williams TA, et al · · 2021 · cited 22× · PMID 34376577 · DOI 10.1158/1535-7163.mct-20-0638
4. Molecular subclassification of gastrointestinal cancers based on cancer stem cell traits.
   Li MM, Yuan J, Guan XY, Ma NF, et al · · 2021 · cited 10× · PMID 34774101 · DOI 10.1186/s40164-021-00246-x
5. Towards Precision Oncology: The Role of Smoothened and Its Variants in Cancer.
   Nicheperovich A, Townsend-Nicholson A. · · 2022 · cited 8× · PMID 36294790 · DOI 10.3390/jpm12101648
6. A Review of Hedgehog Signaling in Radioresistant Esophageal Cancer: Potential Treatment Target.
   Ma L, Wang Y, Chen P, Wu S. · · 2023 · cited 5× · PMID 37066520 · DOI 10.1177/15330338231169873
7. Predicting Response to Neoadjuvant Therapy in Oesophageal Adenocarcinoma.
   Jiang W, de Jong JM, van Hillegersberg R, Read M. · · 2022 · cited 3× · PMID 35205743 · DOI 10.3390/cancers14040996