A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN… (NCT04282590) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN (Chopin Study)
Stopped: due to COVID-19 pandemic
0Started 2020-04
Plain-language 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).
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events as assessed by CTCAE v5.0
Timeframe: 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)
Timeframe: Up to Week 28
3
Proportion of patients with clinically significant changes in electrocardiogram time intervals
Timeframe: Up to Week 24
4
Proportion of patients with clinically significant changes in clinical laboratory tests
. 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.
Exclusion criteria
. 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
. 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.