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Chemotherapy-induced Peripheral NeuropathyPhase 1NCT05251727

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

A Phase 1 study testing thrombomodulin alfa in people with Chemotherapy-induced Peripheral Neuropathy, run by Veloxis Pharmaceuticals at 32 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
thrombomodulin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
32 sitesin 2 countries
Study dates
24 Mar 2022to 5 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

United States18 sites

  • American Oncology Partners, P.A.

    Bethesda, Maryland, 20817

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90210

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59101

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Site #120

    Dallas, Texas, 75230

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

  • Site #115

    Hackensack, New Jersey, 07601

  • Site #114

    Houston, Texas, 77024

  • Horizon Oncology Research, Inc.

    Lafayette, Indiana, 47905

  • UCLA Dept. of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

  • Nashville Oncology Associates, PC

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360

  • Mid-Florida Hematology & Oncology Centers

    Orange City, Florida, 32763

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • MultiCare Regional Cancer Center

    Tacoma, Washington, 98405

Other trials in United States

Japan14 sites

  • NHO Kyushu Cancer Center

    Fukuoka

  • Gifu University Hospital

    Gifu

  • Kagawa University Hospital

    Kita-gun

  • Kitakyushubyoin Kitakyusyu General Hospital

    Kitakyushu-shi

  • Kumpukai Sano Hospital

    Kobe

  • Kurashiki Central Hospital

    Kurashiki-shi, Okyama, 710-8602

  • NHO Shikoku Cancer Center

    Matsuyama

  • Kochi Medical School Hospital

    Nankoku-shi

  • NHO Osaka National Hospital

    Osaka

  • Osaka General Medical Center

    Osaka

  • Tonan Hospital

    Sapporo

  • Shizuoka Cancer Center

    Sunto-gun

  • University of Tsukuba Hospital

    Tsukuba

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

About this study

Official title: Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

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

Read the detailed 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

Being tested
thrombomodulin alfa, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thrombomodulin alfaDrug

    Also called ART-123

    Weight based dose of reconstituted treatment

  • PlaceboDrug

    Weight based dose of reconstituted treatment

Study groups in NCT05251727
Study groupRoleWhat they receive
Lowest DoseExperimentalLyophilized 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)
Receives: Drug: thrombomodulin alfa
Low DoseExperimentalLyophilized 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)"
Receives: Drug: thrombomodulin alfa
Medium DoseExperimentalLyophilized 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)"
Receives: Drug: thrombomodulin alfa
High DoseExperimentalLyophilized 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)"
Receives: Drug: thrombomodulin alfa
Highest DoseExperimentalLyophilized 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)"
Receives: Drug: thrombomodulin alfa
PlaceboPlacebo comparatorLyophilized 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)"
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

    Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after the start of the first dose of investigational medicinal product (IMP)

    Measured: From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks

  2. Number and Percentage of Participants with Serious TEAEs

    Number and percentage of participants experiencing one or more serious adverse events which occurred or worsened in severity after the start of the first dose of IMP

    Measured: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks

  3. Number and Percentage of Participants with TEAEs Leading to Death

    Number and percentage of participants with TEAEs that resulted in death

    Measured: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks

  4. Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation

    Number and percentage of participants with TEAEs that lead to discontinuation of IMP

    Measured: From start of first IMP dose (Cycle 1, Day 1) through planned third IMP dose; planned for 4 weeks

  5. Number and Percentage of Participants with Bleeding Events

    Number and percentage of participants experiencing bleeding events

    Measured: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks

  6. Number and Percentage of Participants with Serious Bleeding Events

    Number and percentage of participants with bleeding events that represent serious adverse events

    Measured: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks

  7. Number and Percentage of Participants with Dose Limiting Toxicity (DLT)

    Number and percentage of participants experiencing DLT

    Measured: From start of first IMP dose (Cycle 1, Day 1) until the start of the third IMP dose; planned for 4 weeks

  8. Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results

    Descriptive statistics will summarize the following by cohort: red blood cell count, hemoglobin, hematocrit, white blood cell count, white blood cell differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count

    Measured: 6 weeks

  9. Number and Percentage of Participants with Abnormal Serum Chemistry Results

    Descriptive statistics will summarize the following by cohort: aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, total bilirubin, total protein, albumin, blood urea nitrogen, creatinine, glucose, and electrolytes (sodium, potassium, chloride)

    Measured: 6 weeks

  10. Number and Percentage of Participants with Abnormal Coagulation Panel Results

    Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT)

    Measured: 6 weeks

  11. Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results

    Qualitative summary of the following by cohort: protein, glucose, and occult blood

    Measured: 6 weeks

  12. Number and Percentage of Participants with Abnormal Vital Signs

    Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure

    Measured: 6 weeks

  13. Number and Percentage of Participants with Anti-ART-123 Antibodies

    Number and Percentage of Participants with detectable anti-ART-123 antibodies; samples testing positive for anti-ART-123 antibodies will be tested for the presence of neutralizing antibodies

    Measured: 6 weeks

Secondary outcomes (4)

  1. Plasma Concentrations of Thrombomodulin

    Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days)

    Measured: Cycle 1, Day 1 (each cycle is 14 days)

  2. Plasma Concentrations of 5-fluorouracil (5-FU)

    Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days)

    Measured: Cycle 1, Day 1 (each cycle is 14 days)

  3. Plasma Concentrations of Oxaliplatin

    Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)

    Measured: Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)

  4. Serum Concentrations of Bevacizumab

    Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)

    Measured: Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start24 Mar 2022
  3. Primary completion5 Jun 2024
  4. Study completion5 Jun 2024

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05251727
Sponsor's protocol ID
ART-123.PN101
Status last verified
Aug 2024
First submitted
7 Jan 2022
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing thrombomodulin alfa in people with Chemotherapy-induced Peripheral Neuropathy, run by Veloxis Pharmaceuticals at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05251727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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