A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo

February 2, 2022 updated by: Veloxis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo

To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Unresectable 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:

  • Prior treatment history with nerve toxic chemotherapeutic agent
  • Peripheral neuropathy or central nervous system damage
  • Psychiatric disorder
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose
Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
Drug: thrombomodulin alfa
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
Other Names:
  • ART-123
Experimental: High Dose
Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
Drug: thrombomodulin alfa
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
Other Names:
  • ART-123
Placebo Comparator: Placebo
Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
Drug: Placebo
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
Time Frame: 9 months
Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months
9 months
FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)
Time Frame: Cycle 9 (each cycle is 2 weeks)
Proportion of subjects scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
Time Frame: Cycle 9 (each cycle is 2 weeks)
Cumulative incidence of scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 through Cycle 9
Cycle 9 (each cycle is 2 weeks)
FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (feet) at Cycle 9
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline score of NRS (Pain) in feet at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (hands) at Cycle 9
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline score of NRS (Pain) in hands at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
Side Effect Questionnaire Score
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline score of Side effect questionnaire at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Sensory Neuropathy
Time Frame: Cycle 9 (each cycle is 2 weeks)
Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Motor Neuropathy
Time Frame: Cycle 9 (each cycle is 2 weeks)
Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
mTCNS Score
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline in total score of mTCNS at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
Grooved Pegboard Change
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)
EQ-5D-5L Change
Time Frame: Cycle 9 (each cycle is 2 weeks)
Change from baseline in EQ-5D-5L index value at the end of Cycle 9
Cycle 9 (each cycle is 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veloxis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Fineberg, MD, Veloxis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3-2001B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings