Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

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About the study

To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 18 years of age or older
  2. Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
  3. ECOG performance status of 0 or 1
  4. The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
  5. Able to sufficiently understand the clinical study and give written informed consent

EXCLUSION CRITERIA

Exclusion Criteria:

  1. History of major hemorrhage
  2. High risk of hemorrhage
  3. History of other malignancies
  4. Active ulcer
  5. Patients using anti-coagulants and fibrinolytic drugs
  6. Active Hepatitis B, or known HBs antigen positive
  7. Prior treatment history with thrombomodulin alfa
  8. Administration of another investigational medicinal product within 30 days prior to randomization
  9. Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
  10. Patients otherwise deemed as inappropriate to participate in the study by the Investigator
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Chemotherapy-induced Peripheral Neuropathy
Age (in years)
18+
Phase
Phase 1
Participants needed
80
Est. Completion Date
Sep 30, 2024
Treatment type
Interventional

Sponsor
Veloxis Pharmaceuticals
ClinicalTrials.gov identifier
NCT05251727
Study number
ART-123.PN101

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