OXL-induced chronic neuropathy. MedDRA version: 14.1 Level: PT Classification code 10029350 Term: Neurotoxicity System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: E-52862
Pharmaceutical Form: Capsule, hard
CAS Number: 878141-96-9
Current Sponsor code: E-52862
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Sponsors
Laboratorios del Dr. Esteve, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Being of either sex aged 18 to 80 years. -Having a diagnosis of colorectal cancer made within the prior 2 years. -Having not received chemotherapy with cytotoxic drugs in the past. -Being schedule to start and adjuvant or palliative 6-month chemotherapy regimen for the treatment of their colorectal cancer that includes OXL at a scheduled dose in the first cycle > or equal 60 mg/m2 in a 2-hour infusion (protocols FOLFOX4 and FOLFOX6, with or without cetuximab or bevacizumab supplementation). -Having with a Karnofsky performance status score > or = 70 at screening visit. -Provide a written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: -Pregnant or nursing women. Fertile women must use a reliable contraceptive method to participate in the study. -Patients with any neurologic condition that might interfere with the evaluation of the study objectives, in particular sensory neuropathies (post-herpetic neuralgia, diabetic neuropathy, HIV-related polyneuropathy, central lesions of the somatosensory system such as multiple sclerosis, etc). -Patients with serious and unstable mental illness (symptoms or treatment) that, in the opinion of the investigator, might hamper the conduct of the study. -Patients who have been treated within 30 days prior to screening, are currently treated, or plan to be treated with another investigational product or device during the intended duration of this clinical trial. -Patients with second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator. -Patients with abnormal liver function, renal function impairment or bone marrow impairment in a blood test within 14 days prior to, or at screening. -Patients receiving or who plan to receive any forbidden treatment during the study. -Having a peripheral sensory neuropathy of any NCI-CTCAE grade (>1) at screening visit. -Patients with symptoms suggesting brain metastasis. -Patients with uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. -Patients with a life expectancy shorter than 4 months. -Patients lacking the capacity to understand and provide the required information to achieve the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To establish the efficacy of E-52862 to reduce the incidence and the severity of OXL-induced chronic neuropathy in patients treated for colorectal cancer. ?To explore the efficacy of E-52862 to reduce the severity and duration of OXL-induced acute neuropathy. ?To evaluate whether E-52862 can raise the cumulative total dose of OXL than can be delivered without dose-limiting chronic neuropathy. ?To explore the incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4. ?To explore the incidence of adverse events by severity, of serious adverse events, of adverse events leading to E 52862 discontinuation and of adverse events related to E-52862 by severity. ?To assess E-52862 plasma exposure associated with the treatment.;Secondary Objective: Not applicable.;Timepoint(s) of evaluation of this end point: At the end of the study.;Primary end point(s): Efficacy endpoints: -Evolution of the clinical Total Neuropathy Score (cTNS). -Change from baseline of the reduced Total Neuropathy Score (rTNS). -Evolution of cold-induced pain intensity. -Change from baseline of the number and duration of signs and symptoms of OXL-induced acute neuropathy assessed with the specific OXL-induced neuropathy questionnaire. -Level of peripheral sensory neuropathy toxicity at each visit assessed with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria. -Time to the first occurrence of NCI-CTCAE grade 2, 3 or 4 symptomatic neuropathy. -Change from baseline of the amplitudes of sensory and motor nerve action potentials and of the sensitive and motor nerve conduction velocities measured in the nerve conduction tests. -Evolution of patients's quality of life assessed with the Quality of Life Questionnaire C30 (QLQ-C30) with the module for chemotherapy-induced neuropathy (QLQ-CIPN20). -Proportion of patients who meet any of the following definitions of neuropathy at the end of t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Greece, Spain
Contacts
Public ContactStudy Medical Monitor
Laboratorios del Dr. Esteve S.A.
Outcome results
None listed