A Phase 2 interventional study of Itraconazole in Esophagus Adenocarcinoma, Esophagus Squamous Cell Carcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by Dallas VA Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by Dallas VA Medical Center · Phase 2, Interventional, and Treatment
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Among 246 studies in Adenocarcinoma Of Esophagus with a site in United States — 53 open to participants now, 73 under way, 7 of them phase 3. Adenocarcinoma Of Esophagus · United States.
Among the 246 studies in Adenocarcinoma Of Esophagus with a site in United States, this one is the 61st largest by planned enrollment of the 203 interventional ones that give a count, is one of 6 that started in 2019, is one of 125 in phase 2, reaches primary completion later than 10 of the 72 other live ones, and was the 166th registered.
354 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 81 are open to participants now.
Browse Adenocarcinoma Of Esophagus studies →53 of the 246 studies in Adenocarcinoma Of Esophagus with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Case Comprehensive Cancer Center · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Adenocarcinoma Of Esophagus studies recruiting now, 60 (86%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
246 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 56 · Phase 2 150 · Phase 3 18 · Phase 4 2
First in 1995; this study’s year is marked. 6 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 78 is above the median of 51 across 277 interventional studies indexed under Adenocarcinoma Of Esophagus.
Median enrollment 49 across the 203 interventional studies, 155 across the 23 observational. Of the 156 that completed or were terminated, 63 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
57 of 246 have an industry lead sponsor. The 10 most frequent:
Dallas VA Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Dallas VA Medical Center has 1 study filed under Adenocarcinoma Of Esophagus — fewer than ten, so there is no comparison to draw.
18 of the studies in Adenocarcinoma Of Esophagus with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06203600Phase 3National Cancer Institute (NCI)Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial | 2027-10-31 |
| NCT02962063Memorial Sloan Kettering Cancer CenterDurvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer | 2026-11 |
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT07023731Arvinas Inc.A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation | 2026-11-30 |
| NCT04900818I-Mab Biopharma US LimitedStudy of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors | 2026-12 |
Add all 18 to your calendar (.ics) → With an account.
Among the 246 studies in Adenocarcinoma Of Esophagus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Esophageal cancer has a high incidence rate in the United States, and novel approaches to its treatment are being studied. Itraconazole, an antifungal agent, has been shown to inhibit the Hedgehog (Hh) and AKT signaling pathways, which are upregulated in esophageal cancer and promote tumor cell growth. This study will evaluate whether the use of itraconazole leads to increased rates of pathological complete response (pathCR) by at least 15% from the historical pathCR rate of 25% in patients with esophageal cancer or gastroesophageal junction (GEJ) adenocarcinoma. The investigators will enroll approximately 78 patients with esophageal cancer or GEJ adenocarcinoma who will then undergo standard of care staging work-up with a PET/CT and endoscopic ultrasound (EUS). In a subset of patients, biopsies will be obtained to assess the status of the Hh and AKT signaling pathways by PCR, Western blot, and immunohistochemistry in the primary tumor before treatment. If no distant metastases are found, all patients will undergo 5-6 weeks of standard of care neoadjuvant chemoradiation. Following this, all patients will be given itraconazole 300 mg twice daily for 6-8 weeks. Adverse effects to itraconazole will be monitored in oncology clinic. If standard restaging PET/CT following neoadjuvant chemoradiation does not reveal new metastases, the patient will undergo an esophagectomy. Samples from normal esophageal tissue will be analyzed for presence of itraconazole and its metabolites to determine if the patients were taking the study drug. Tumor tissue will be evaluated for status of Hh pathway activation, AKT and VEGFR2 phosphorylation, Ki67 immunostaining, and other molecular pathways with comparisons made to pre-treatment biopsies if available. The final pathology report will indicate whether the patient has achieved pathCR. Because the Hh signaling pathway is a resistance pathway that can be upregulated in response to chemoradiation, the investigators believe that administering itraconazole following neoadjuvant chemoradiation will lead to a higher pathCR rate. This in turn should be able to improve treatment outcomes in patients with esophageal cancer and GEJ adenocarcinoma.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Itraconazole capsule 300mg twice daily for 6-8 weeks following chemoradation.
Drug: Itraconazole
Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.
Percentage of pathological complete response with itraconazole
Generally for esophageal cancer the pathological complete response rate at time of esophagectomy is 25%, and we have designed our study with the projected number of patients assuming we observe an improvement of 15% or more in this rate following treatment with itraconazole. This is the study's primary endpoint. By inhibiting the Hh signaling pathway with the use of itraconazole, we anticipate improved pathological complete response rates.
Time frame: 3-4 months
Comparison of hedgehog biomarkers before and after intervention
As part of clinical staging, patients will undergo endoscopic ultrasound (EUS) following a PET/CT that does not show metastases. During EUS, some patients will undergo eight research biopsies obtained with large forceps for research purposes at the level of the visualized esophageal mass or abnormality (3 for RNA isolation, 3 for protein isolation, and 2 for formalin fixation). Three research biopsies for RNA isolation will also be obtained from normal appearing esophagus, at least 5 cm away from any mass lesions. The research biopsies will be submitted to qPCR analysis for mRNA expression levels of SHH, IHH, PTCH, GLI1, GLI2, and GLI3 (Hedgehog pathway components). Comparisons will be made between mass biopsies and normal esophageal tissues. Following esophagectomy, tissues will be analyzed for the aforementioned hedgehog pathway markers to determine response to therapy.
Time frame: 3-4 months
Comparison of phosphorylated VEGFR2 and AKT before and after intervention
Tissue obtained prior to initiation of chemoradiation will be analyzed with Western blot to quantify presence of VEGFR2 and AKT. These markers will again be analyzed following esophagectomy to determine response to therapy.
Time frame: 3-4 months
Levels of itraconazole and metabolites in esophageal tissue
The concentration of itraconazole and hydroxy-itraconazole in normal esophageal tissue will be measured following esophagectomy to ensure that the drug has been taken consistently.
Time frame: 1 month.
Started Jun 2019 (actual). Primary completion is estimated for Jun 2026, 84 months after the start.
Of 51 non-industry phase 2 interventional studies under Adenocarcinoma Of Esophagus, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 84 months is above that.
Counting every sponsor, half of 60 studies reached it within 55 months; a quarter within 41 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Itraconazole
Dallas VA Medical Center