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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 December 2021 |
Main ID: |
EUCTR2005-002570-30-HU |
Date of registration:
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29/09/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA
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Scientific title:
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A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA |
Date of first enrolment:
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11/11/2005 |
Target sample size:
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900 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002570-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Germany
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Hungary
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Italy
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Portugal
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: - Histologically or cytologically-proven metastatic cancer of the colon or rectum. - Metastatic disease not curable by surgery or amenable to radiation therapy with curative intent. - Male or female aged =18 years. - WHO Performance Status (PS) : 0 or 1. - At least one unidimensionally measurable lesion with a diameter =20 mm using conventional CT or MRI scans or =10 mm using spiral CT scans. If a single lesion is identified as the target lesion, a histological or cytological confirmation of adenocarcinoma from that lesion is required. - No prior chemotherapeutic regimen for metastatic disease. - Prior adjuvant chemotherapy for non-metastatic disease with 5-FU/LV, with 5- FU/levamizole, with irinotecan/5-FU/LV, with capecitabine is allowed. In case of prior adjuvant chemotherapy, the Disease-Free interval from end of the adjuvant therapy should be greater than 6 months. - Prior adjuvant chemotherapy with oxaliplatin/5-FU/LV is allowed provided the progression free interval from end of adjuvant therapy is greater than 12 months. - Serum creatinine =1.5 X the institution’s ULN. - Have adequate organ function and be medically stable. - Signed written informed consent (approved by the Ethics Committee) obtained prior to study-specific screening procedure. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information. - Peripheral neuropathy >Grade 1 (as defined by the NCI CTCAE version 3.0). - Undetectable Sensory Action Potential (SAP) of both sural nerves as shown by the baseline nerve conduction studies (NCS). - Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy: Ca/Mg, carbamazepine, amitriptyline, gabapentin, phenytoin, gluthatione, alpha-lipoic acid, celecoxib, amifostine, venlaflaxine, vitamin B1 (thiamine), B6 (pyridoxine). - Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive heart failure (NY Heart Association Classification III or IV), serious cardiac arrhythmia, diabetes, or active infection. - Presence of any symptom suggesting brain metastasis.
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV; at risk of cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin. MedDRA version: 8
Level: LLT
Classification code 10034620
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Intervention(s)
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Product Name: Xaliproden hydrochloride Product Code: SR57746A Pharmaceutical Form: Capsule, hard INN or Proposed INN: Xaliproden hydrochloride CAS Number: 90494-79-4 Current Sponsor code: SR57746A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: Neuroprotection: Reduction in the risk of occurrence of Grade 3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin.
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Primary end point(s): Primary efficacy endpoint is the probability of occurrence of Grade 3-4 PSN relative to the cumulative dose of oxaliplatin estimated using the Kaplan-Meier method and compared between the two treatment groups using a 2-sided logrank test with a type I error of 0.05.
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Secondary Objective: 1- Main secondary objective: -Chemotherapy efficacy: Response Rate (RR) between the control arm A and the experimental arm B in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden.
2-Other secondary objectives: -Neuroprotection: • Duration of oxaliplatin-induced PSN (Grade 2, 3, 4). • Overall incidence of PSN during treatment by patient and by grade (Grades 1, 2, 3-4). • Dose to onset of PSN (Grades 1, 2, 3-4). • Incidence of dose-reduction and dose-delay due to PSN. • Incidence of oxaliplatin treatment discontinuation due to PSN. • Change in Nerve Conduction Studies (NCS).
-Safety profile (other than PSN) -Chemotherapy efficacy: • Progression Free Survival (PFS) • Overall survival (OS).
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Secondary ID(s)
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2005-002570-30-GB
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EFC5505
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 02/11/2005
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