Nitazoxanide in Patients With Metastatic Colorectal Cancer

Last updated: September 17, 2023
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

3

Condition

Colorectal Cancer

Metastatic Cancer

Treatment

Nitazoxanide

Clinical Study ID

NCT06049901
Nitazoxanide in mCRC
  • Ages 18-65
  • All Genders

Study Summary

The aim of this study is to evaluate the potential efficacy and safety of nitazoxanide in patients with metastatic colorectal cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will beperformed according to the American Joint Committee on Cancer (AJCC) 8th edition andwill be documented by all investigating parameters of metastatic CRC
  2. Male or female patients with age range from 18-65 years old
  3. Women of childbearing age will be required to be on acceptable forms of contraception
  4. No contraindication to chemotherapy (absence of myelosuppression)
  5. Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG)score
  6. Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < grade 2) according to the National Cancer Institute-Common TerminologyCriteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
  7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) < grade 2) according to NCI-CTCAE, v 5.0
  8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes andabsolute neutrophil count (ANC) < grade 2 according to NCI-CTCAE, v 5.0

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Patients who have known allergy to nitazoxanide or its metabolites
  3. Patients with concurrent active cancer originating from a primary site other than thecolon or rectum
  4. Patients who are receiving highly plasma protein-bound drugs or drugs with extensivehepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs andanti-epileptic drugs

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Nitazoxanide
Phase: 3
Study Start date:
March 01, 2023
Estimated Completion Date:
March 31, 2026

Study Description

Globally, colorectal cancer (CRC) is a major malignant tumor of the gastrointestinal tract which originates from epithelial cells of the colon and rectum. The efficacy of current cancer therapies is still limited by severe adverse effects on normal tissues and chemoresistance development. Therefore, recent efforts have been focused on the repurposing of existing drugs with good safety profiles for cancer treatment.

Nitazoxanide (NTZ) is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses. NTZ inhibited the proliferation of CRC cell lines at or below concentrations that normally exhibit anti-parasitic activity.

Connect with a study center

  • Tanta University Hospital

    Tanta, El-Gharbia Governorate 31527
    Egypt

    Active - Recruiting

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