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

V

Veloxis Pharmaceuticals

Status and phase

Terminated
Phase 1

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Drug: Placebo
Drug: thrombomodulin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT05251727
ART-123.PN101

Details and patient eligibility

About

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

Full description

To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years of age or older
  • Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
  • ECOG performance status of 0 or 1
  • 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
  • Able to sufficiently understand the clinical study and give written informed consent

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

77 participants in 6 patient groups, including a placebo group

Lowest Dose
Experimental group
Description:
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)
Treatment:
Drug: thrombomodulin alfa
Low Dose
Experimental group
Description:
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Treatment:
Drug: thrombomodulin alfa
Medium Dose
Experimental group
Description:
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Treatment:
Drug: thrombomodulin alfa
High Dose
Experimental group
Description:
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Treatment:
Drug: thrombomodulin alfa
Highest Dose
Experimental group
Description:
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Treatment:
Drug: thrombomodulin alfa
Placebo
Placebo Comparator group
Description:
Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Treatment:
Drug: Placebo

Trial contacts and locations

32

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Central trial contact

Pamela Allton

Data sourced from clinicaltrials.gov

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