Chemotherapy-induced Peripheral NeuropathyPhase 2NCT04492436
A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
A Phase 2 study testing thrombomodulin alfa in people with Chemotherapy-induced Peripheral Neuropathy, run by Veloxis Pharmaceuticals.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jul 2024
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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
Read the 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
- 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 administered through intravenous drip infusion on Day1 of each chemotherapy cycle
PlaceboDrug
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 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. Receives: Drug: thrombomodulin alfa |
| High Dose | Experimental | 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. Receives: Drug: thrombomodulin alfa |
| Placebo | Placebo comparator | Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
Secondary outcomes (12)
FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months
Measured: 9 months
FACT/GOG-NTX-12 (4 items) Proportional Score at 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
Measured: Cycle 9 (each cycle is 2 weeks)
FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
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
Measured: Cycle 9 (each cycle is 2 weeks)
FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9
Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (feet) at Cycle 9
Change from baseline score of NRS (Pain) in feet at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (hands) at Cycle 9
Change from baseline score of NRS (Pain) in hands at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
Side Effect Questionnaire Score
Change from baseline score of Side effect questionnaire at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Sensory Neuropathy
Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Motor Neuropathy
Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
mTCNS Score
Change from baseline in total score of mTCNS at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
Grooved Pegboard Change
Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
EQ-5D-5L Change
Change from baseline in EQ-5D-5L index value at the end of Cycle 9
Measured: Cycle 9 (each cycle is 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startOct 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Study design was changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veloxis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fineberg, MD, Study director, Veloxis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492436
- Sponsor's protocol ID
- 3-2001B
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04492436
- Acronym / sponsor ID
- 3-2001B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design was changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: thrombomodulin alfaReconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle. |
| High Dose | Experimental | Drug: thrombomodulin alfaReconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle. |
| Placebo | Placebo comparator | Drug: PlaceboReconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombomodulin alfaAlso: ART-123Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle | Drug | High Dose, Low Dose |
| PlaceboWeight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle | Drug | Placebo |
Primary outcome
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
12 secondary outcomes
FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
Time frame: 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)
FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
Time frame: 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)
NRS (Pain) Scores (feet) at Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (hands) at Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
Side Effect Questionnaire Score
Time frame: Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Sensory Neuropathy
Time frame: Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Motor Neuropathy
Time frame: Cycle 9 (each cycle is 2 weeks)
mTCNS Score
Time frame: Cycle 9 (each cycle is 2 weeks)
Grooved Pegboard Change
Time frame: Cycle 9 (each cycle is 2 weeks)
EQ-5D-5L Change
Time frame: Cycle 9 (each cycle is 2 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
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Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Fineberg, MD study director
Veloxis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thrombomodulin alfa in people with Chemotherapy-induced Peripheral Neuropathy, run by Veloxis Pharmaceuticals.
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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9 (time frame: Cycle 9 (each cycle is 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.