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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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19 March 2012 |
Main ID: |
EUCTR2007-000945-36-DE |
Date of registration:
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30/08/2007 |
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 to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer - XENON
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Scientific title:
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A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer - XENON |
Date of first enrolment:
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27/11/2007 |
Target sample size:
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244 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000945-36 |
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: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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France
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Germany
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Greece
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Italy
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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: 1/ Patient’s consent obtained, with Informed Consent Form signed and dated prior to protocol-specific procedures; 2/ Have had an oxaliplatin-containing chemotherapy regimen post complete surgical removal of the primary colon tumor, with the last infusion of oxaliplatin no more than 6 weeks before randomization; (If the fluoropyrimidine alone [iv 5-FU/LV or capecitabine] is continued post discontinuation of oxaliplatin, the patient can be included and xaliproden given concomitantly, however reintroduction of oxaliplatin is not permitted); 3/ Have Grade = 1 PSN, as defined by the NCI-CTCAE version 3.0, 4/ Be at least 18 years of age; 5/ Have an ECOG Performance Status = 2; 6/ Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) =2 UNL; (b) serum creatinine <1.5xUNL; (c) HbA1c <7%; (d) neutrophils >1.5x109/L (e) platelets =50x109/L, (f) Serum D-dimer within normal limits. In case of positive D-dimer, the patient can be included provided that deep venous thrombo-embolism / pulmonary embolism have been ruled out by specific procedures (such as Doppler examination of lower limbs, spiral CT scan of lungs).
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: 1/ Pre-existing peripheral neuropathy prior to treatment with oxaliplatin 2/ Receiving any further anti-cancer treatment (except if the fluoropyrimidine component alone [iv 5-FU/LV or capecitabine] is continued post discontinuation of oxaliplatin [as part of the adjuvant chemotherapy regimen]; however reintroduction of oxaliplatin is not permitted). 3/ History of any recent (= 1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism 4/ Unstable cardiac disease. 5/ History of significant neurological or psychiatric disorders including dementia or seizures, 6/ Active uncontrolled infection 7/ Active disseminated intravascular coagulation 8/ Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; 9/ Use of antidepressant/antiepileptic medication (for the treatment of PSN), unless commenced before informed consent form signed. The addition of these medications (for the treatment of PSN) once the patient has consented is not allowed. 10/ Concurrent treatment with any other experimental drugs. 11/ Pregnant or breast-feeding women; 12/ Women of childbearing potential must be protected by effective contraceptive methods of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential. 13/ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be assessed with the patient before registration in the trial.
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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Patient with oxaliplatin-induced peripheral sensory neuropathy after having completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colorectal tumor MedDRA version: 9.1
Level: LLT
Classification code 10040039
Term: Sensory peripheral neuropathy
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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 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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Secondary Objective: •To assess the effects of xaliproden on patient-reported outcomes using the FACT/GOG NTX-12 subscale.
•To assess the effect of xaliproden on the rate of at least partial recovery of grade =2 PSN at 6 months.
•To assess the effect of xaliproden on the time to complete recovery from PSN
•To evaluate the safety profile of xaliproden
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Main Objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer
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Primary end point(s): Assessemnt of neurological sensory, as graded by the investigator using the NCI-CTCAE (version 3.0).
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Secondary ID(s)
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XALIP_C_02090
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2007-000945-36-FR
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Source(s) of Monetary Support
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Results
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Results available:
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