RecruitingPhase 3NCT06049901
Nitazoxanide in Patients With Metastatic Colorectal Cancer
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Patients With Metastatic Colorectal Cancer
Sponsor
Tanta University
Enrollment
60 participants
Start Date
Mar 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this study is to evaluate the potential efficacy and safety of nitazoxanide in patients with metastatic colorectal cancer.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria8
- Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic CRC
- Male or female patients with age range from 18-65 years old
- Women of childbearing age will be required to be on acceptable forms of contraception
- No contraindication to chemotherapy (absence of myelosuppression)
- Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
- Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
- Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0
- Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0
Exclusion Criteria4
- Pregnant or lactating women
- Patients who have known allergy to nitazoxanide or its metabolites
- Patients with concurrent active cancer originating from a primary site other than the colon or rectum
- Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs
Interventions
DRUGNitazoxanide
Nitazoxanide is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06049901
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