Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Esophageal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Cancer

Anti-Infective Agents

All Drugs and Chemicals

Itraconazole

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.

Oral administration of itraconazole twice daily concurrent with chemoradiation

itraconazole

Shixiu Wu, phD

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer

Esophageal cancer is one of the most lethal malignancies. Esophageal squamous cell carcinoma (ESCC) is the predominant type in China, accounting for over 90% of all esophageal cancer. Concurrent chemoradiation therapy (CCRT) remains the standard therapy of locally advanced ESCC. However, the outcome remains poor.

The aberrant activation of Hedgehog (HH) signaling is associated with a variety of human malignancies. Previous studies found that the reactivation of HH pathway occurs in 60% of esophageal cancer. Targeting the Hh pathway for cancer therapy was expected to work wonders in Hh-dependent cancers. Itraconazole, an antifungal agent, has been shown to inhibit the Hh and AKT signaling pathways.

The aim of our study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer

CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer

Phase II Study of Concurrent Chemoradiotherapy With Itraconazole in Treating Patients With Locally Advanced Esophageal Squamous Cancer

ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1

Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion.

LRFS was calculated from the date of treatment initiation to the date of documented failure.

OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.

Hangzhou Cancer Hospital

Professor

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.

Itraconazole 200 mg

Renato M Bakos, Ph. D.

Rodrigo P Pereira, M.D.

Renato M Bakos, Ph.D.

Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.

Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.

Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.

The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.

Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.

Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.

tumor area response registered through dermatologic evaluation

Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.

Hospital de Clinicas de Porto Alegre

Symptoms and General Pathology

Neoplasm Metastasis

Syndrome

Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

BMS-833923 (XL139)

Bristol-Myers Squibb

The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule

A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

A Phase 1 Multiple Ascending Dose Study of BMS-833923 in Subjects With Advanced or Metastatic Solid Tumors

Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923

glioma-associated oncogene family of transcription factors (GLI)

Tumor assessments by computed tomography (CT)

The results of vital sign measurements, electrocardiogram (ECGs), pulmonary function tests, multigated radionuclide angiography (MUGA) or echocardiograms, physical examinations, and clinical laboratory tests

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer	NCT04481100	Esophageal Neop... Esophageal Dise... Esophageal Squa...	itraconazole	18 Years - 75 Years	Hangzhou Cancer Hospital
Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.	NCT03972748	Basal Cell Carc... Hedgehog Pathwa...	Itraconazole 20...	18 Years -	Hospital de Clinicas de Porto Alegre
A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer	NCT00670189	Hedgehog Pathwa... Smoothened Basal Cell Carc... Basal Cell Nevo...	BMS-833923 (XL1...	18 Years -	Bristol-Myers Squibb
A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer	NCT00670189	Hedgehog Pathwa... Smoothened Basal Cell Carc... Basal Cell Nevo...	BMS-833923 (XL1...	18 Years -	Bristol-Myers Squibb

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