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ART-123 + Chemotherapy for Colorectal Cancer

Phase 1
Recruiting
Research Sponsored by Veloxis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)
Awards & highlights

Study Summary

This trial is testing a new drug, ART-123, to see if it is safe and effective in treating metastatic colorectal cancer.

Who is the study for?
This trial is for adults over 18 with metastatic colorectal cancer and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants must have normal recent liver and kidney tests, agree to use effective contraception, and be able to consent. Excluded are those with a high bleeding risk, other cancers, active ulcers, hepatitis B, prior thrombomodulin alfa treatment or recent investigational drug use.Check my eligibility
What is being tested?
The study is testing the safety of ART-123 when added to FOLFOX (a type of chemotherapy) plus Bevacizumab in treating metastatic colorectal cancer. Patients will either receive ART-123 or a placebo alongside their standard chemotherapy regimen to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include increased risk of bleeding due to ART-123's effect on blood clotting; common chemo-related issues like nausea, fatigue, neuropathy; and Bevacizumab's risks such as hypertension and rare severe bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of colon or rectum cancer that has spread to other parts.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Percentage of Participants with Abnormal Coagulation Panel Results
Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results
Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results
+10 more
Secondary outcome measures
Plasma Concentrations of 5-fluorouracil (5-FU)
Plasma Concentrations of Oxaliplatin
Plasma Concentrations of Thrombomodulin
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium DoseExperimental Treatment1 Intervention
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)"
Group II: Lowest DoseExperimental Treatment1 Intervention
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)
Group III: Low DoseExperimental Treatment1 Intervention
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)"
Group IV: Highest DoseExperimental Treatment1 Intervention
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)"
Group V: High DoseExperimental Treatment1 Intervention
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)"
Group VI: PlaceboPlacebo Group1 Intervention
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)"

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
3,066 Total Patients Enrolled
Aimee Liu, MD PhDStudy DirectorVeloxis Pharmaceuticals
Shailesh G. Chavan, MDStudy DirectorVeloxis Pharmaceuticals
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

thrombomodulin alfa Clinical Trial Eligibility Overview. Trial Name: NCT05251727 — Phase 1
Peripheral Neuropathy Research Study Groups: Placebo, Lowest Dose, High Dose, Highest Dose, Low Dose, Medium Dose
Peripheral Neuropathy Clinical Trial 2023: thrombomodulin alfa Highlights & Side Effects. Trial Name: NCT05251727 — Phase 1
thrombomodulin alfa 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251727 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation limit of this medical trial?

"The sponsor, Veloxis Pharmaceuticals, needs to recruit 80 eligible patients across multiple locations. Specifically, they are working out of Site #113 in Beverly Hills and Site#101 in Bethesda."

Answered by AI

How widely dispersed is the management of this research study?

"This clinical trial is now accepting patients from 7 distinct sites, including three major cities such as Beverly Hills, Bethesda and Orange City. To reduce the burden of travelling, it's advantageous to select a site close by when enrolling."

Answered by AI

Are there still vacancies for participants in this trial?

"Affirmative, according to the information hosted on clinicaltrials.gov this medical experiment is accepting applications for patient recruitment. It has been in operation since March 24th 2022 with its most recent update occurring on May 26th 2022. The trial aims to enrol 80 participants from 7 different sites."

Answered by AI

Are there any safety risks associated with thrombomodulin alfa?

"Since this is a Phase 1 trial, with limited data demonstrating its safety and efficacy, thrombomodulin alfa earned a score of 1."

Answered by AI

What are the expected results of this experiment?

"As indicated by the research sponsor, Veloxis Pharmaceuticals, their primary goal is to measure how many participants have abnormal Complete Blood Count (CBC) results over a 6 week period. Additionally, this trial will assess secondary endpoints such as levels of thrombomodulin at cycle 1 dosing intervals, concentrations of 5-fluorouracil after cycle 1 dosages and serum bevacizumab concentrations during both Cycle 1 and 3."

Answered by AI

Who else is applying?

What site did they apply to?
Englewood Hospital and Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
2022. "Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05251727.
All > Peripheral Neuropathy
~6 spots leftby Jul 2024
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