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Chemotherapy-induced Peripheral NeuropathyPhase 2NCT04282590

A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN (Chopin Study)

A Phase 2 study of Chemotherapy-induced Peripheral Neuropathy, run by Toray Industries, Inc.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary objective of the study is: to assess the safety and tolerability of multiple oral (twice daily [BID]) doses of TRK-750 in oxaliplatin-treated colorectal cancer patients with chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study

Who is it for?
Ages 18 to 80 years
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2020to Dec 2021
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient between 18 and 80 years of age, inclusive.
  • Oxaliplatin-containing chemotherapy treatment for colorectal cancer in the adjuvant setting must have been completed ≥ 3 months, but not more than 3 years, prior to Screening.
  • A diagnosis of CIPN based on the following criteria:
  • onset of pain of any severity in hands and/or feet after exposure to oxaliplatin AND;
  • presence of painful symptoms of any severity in a symmetrical stocking and glove distribution beginning in lower extremities, which may progress to the upper extremities (the latter may or may not be present at study entry) AND;
  • painful symptoms are accompanied by non-painful symptoms (e.g., tingling or numbness) in a similar distribution.
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  • Neuropathy of ≥ Grade 2 using the general guideline of grading scales defined in CTCAE (v5.0)
  • Pain or neuropathic symptoms of CIPN for a duration of ≥ 3 months, for which the patient wants intervention.
  • Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
  • Females of childbearing potential will agree to use highly effective contraception (Appendix 4) from the time of signing the ICF until 90 days after the Follow-up visit. Males who are sexually active with female partners of childbearing potential will agree to use a male condom with spermicide from Day 1 until 90 days after the Follow-up visit.
  • Be either CIPN pain-treatment naïve or have important side effects or inadequate relief from their current CIPN pain medication (stable over last month).
  • Has not used non-pharmacological therapy for the treatment of any pain condition (e.g., chiropractic therapies, alternative medicine therapies, or acupuncture) for at least 2 weeks prior to start of the baseline days (Days -14 to -1), and a willingness to refrain from using these therapies throughout the study. The use of physical activity or other short-acting, symptomatic non-pharmacological therapy is permitted provided the patient is willing to maintain the same regimen or usage pattern consistently throughout the study.
  • Able to comprehend and willing to sign an Informed Consent Form (ICF) and to abide by the study restrictions.
  • Patients have a life expectancy of at least 12 months.
  • An EORTC QLQ-CIPN20 score of ≥ 25 based on an average of 2 assessments during the Screening period and Day 1 prior to randomisation.
  • At least one of the following:
  • a mean value of pain intensity ≥ 4 on the 11-point NRS based on the average of once-daily assessments for 7 days, with no more than 2 missing records, between Days -7 and -1. Patients must score ≥ 4 on at least 4 out of 7 measurements between Days -7 and -1 OR;
  • a mean value of intensity of tingling and numbness or uncomfortable neuropathic symptoms ≥ 4 on the 11-point NRS based on the average of once-daily assessments for 7 days, with no more than 2 missing records, between Days -7 and -1. Patients must score ≥ 4 on at least 4 out of 7 measurements between Days -7 and -1.

Who cannot join

  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, ability to complete the study, and study assessments.
  • Presence of skin conditions in the affected dermatome that, in the judgement of the Investigator, could interfere with evaluation of the neuropathic pain condition.
  • Presence of non-CIPN pain that may interfere with study assessments and/or self-evaluation of peripheral neuropathic pain.
  • Known history of significant hypersensitivity, intolerance, or allergy.
  • Peripheral neuropathy caused by tumour infiltration or compression of spinal nerves or surgical trauma.
  • Active clinically significant infection
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  • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry.
  • Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis.
  • History of pre-existing symptomatic neuropathy prior to chemotherapy, including neuropathy due to alcoholism, vitamin B deficiency, diabetes, hypothyroidism, human immunodeficiency virus (HIV), congenital neuropathy, and toxic neuropathy.
  • Female patients who are pregnant (including a positive urine pregnancy test at Screening or on Day 1) or lactating.
  • Inadequate haematological function, defined as neutrophil count < 1.0 × 10^9/L and platelet count < 50 × 10^9/L with measured values of these in the clinical laboratory tests conducted at Screening. At Screening, haematology assessments may be repeated once.
  • Inadequate renal function, defined as estimated glomerular filtration rate (eGFR) ≤ 59 mL/min, i.e., Creatinine Clearance (CrCl) as calculated using the Cockcroft-Gault equation with measured values of these in the clinical laboratory tests conducted at Screening:
  • [1.23 × (140 - age) × (weight in kg)] ÷ (serum creatinine in μmol/L) - if male.
  • [1.04 × (140 - age) × (weight in kg)] ÷ (serum creatinine in μmol/L) - if female.
  • At Screening, clinical laboratory assessments may be repeated once.
  • History of alcoholism or drug/chemical abuse within 1 year prior to Day 1.
  • Positive test results for drugs of abuse at Screening (confirmed by repeat) or Day 1, unless consistent with use of prescription medication and approved by the Sponsor (or delegate). A repeated positive test result for cocaine, phencyclidine, methadone, or amphetamines, for nonmedical use, are unconditionally exclusionary.
  • Positive test for hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV), or HIV antibody at Screening.
  • Use of any medication in the absence of appropriate washout periods that, in the opinion of the Investigator, may influence the result of the study, or the patient's ability to participate in the study.
  • Has received an investigational product or has been treated with an investigational device within 90 days prior to first drug administration and will not start any other investigational product or device study within 90 days after last study drug administration.
  • Likely to require chemotherapy during the study period or any other treatment that may interfere with compliance with the protocol, ability to complete the study, and study assessments.
  • Plans to change current medications or any other intervention intended to treat or relieve CIPN signs or symptoms from Screening to end of study.
  • Has previously received TRK-750.

About this study

Official title: A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TRK-750 in Colorectal Cancer Patients With Chemotherapy-induced Peripheral Neuropathy Following Oxaliplatin-containing Chemotherapy in the Adjuvant Setting

The primary objective of the study is:

  • to assess the safety and tolerability of multiple oral (twice daily [BID]) doses of TRK-750 in oxaliplatin-treated colorectal cancer patients with chemotherapy-induced peripheral neuropathy (CIPN).
Read more

The secondary objectives of the study are:

  • to assess the efficacy of multiple oral (BID) doses of TRK-750 in reducing neuropathic symptoms, improving quality of life (QoL), and clinician-reported outcomes in oxaliplatin-treated colorectal cancer patients with CIPN.
  • to study the relationship between plasma concentrations of TRK-750 and safety and efficacy variables in oxaliplatin-treated colorectal cancer patients with CIPN.

The exploratory objective of this study is:

  • to assess the efficacy of multiple oral (BID) doses of TRK-750 on pharmacodynamic (PD) biomarker(s) in blood, psychophysical, electrophysiological, and histological parameters of neuropathy in oxaliplatin-treated colorectal cancer patients with CIPN.
Being tested
TRK-750/Placebo, Placebo/TRK-750

What participants receive

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

  • TRK-750/PlaceboDrug

    Powder for oral solution

  • Placebo/TRK-750Drug

    Powder for oral solution

Study groups in NCT04282590
Study groupRoleWhat they receive
Treatment Period 1: TRK-750, Treatment Period 2: placeboExperimentalNot described
Receives: Drug: TRK-750/Placebo
Treatment Period 1: placebo, Treatment Period 2: TRK-750ExperimentalNot described
Receives: Drug: Placebo/TRK-750

What is being measured

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

  1. Incidence of adverse events as assessed by CTCAE v5.0

    Measured: Up to Week 28

  2. Proportion of patients with clinically significant changes in vital signs: supine blood pressure (mmHg), supine pulse rate (beats/min), respiratory rate (breaths/min), and oral body temperature (°C or °F)

    Measured: Up to Week 28

  3. Proportion of patients with clinically significant changes in electrocardiogram time intervals

    Measured: Up to Week 24

  4. Proportion of patients with clinically significant changes in clinical laboratory tests

    Measured: Up to Week 28

Secondary outcomes (8)

  1. Absolute change and percentage change of Numerical Rating Scale (NRS) from baseline in neuropathic symptoms

    Pain and distressing neuropathic symptoms intensities will be assessed for neuropathic symptoms.

    • for pain intensity: weekly average of NRS daily (evening) assessments.
    • for distressing neuropathic symptoms such as tingling and numbness intensity: weekly average of NRS of daily (evening) assessments.

    Measured: Week 12

  2. Proportion of patients with a reduction of at least 30% relative to baseline in neuropathic symptoms intensity on weekly average of NRS daily assessments

    Measured: Week 12

  3. Change from baseline in EORTC QLQ-CIPN20 patient-reported outcome scale

    Measured: Week 12

  4. Proportion of patients with 2 points or more improvement relative to baseline in EORTC QLQ-CIPN20 sensory subscale assessments

    Measured: Week 12

  5. Change from baseline in EORTC QLQ-C30

    Measured: Week 12

  6. Change from baseline in TNSc

    Measured: Week 12

  7. Change from baseline in CTCAE (v5.0) neuropathy grade.

    Measured: Week 12

  8. Plasma concentrations of TRK-750 (ng/mL)

    Measured: Up to Week 28

Timeline

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

  1. First posted25 Feb 2020
  2. Study startApr 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: due to COVID-19 pandemic

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04282590
Sponsor's protocol ID
750CNP01
Status last verified
Feb 2022
First submitted
17 Feb 2020
Last updated
15 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Chemotherapy-induced Peripheral Neuropathy, run by Toray Industries, Inc.

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 18 inclusion and 23 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 15 Mar 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. 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?

Incidence of adverse events as assessed by CTCAE v5.0 (time frame: Up to Week 28). The study lists 4 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 NCT04282590.

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 15 Mar 2022.

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