A multi-center, 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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000945-36-IT
• Date of registration: 18/12/2007
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis groupe
• Public title: A multi-center, 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
• Scientific title: A multi-center, 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: 21/12/2007
• Target sample size: 244
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000945-36
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

France, Germany, Greece, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1.Patient?s consent obtained, with Informed Consent Form signed and dated prior to protocol-specific procedures; 2.Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of the primary colon tumor no later than 6 weeks before randomization; 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.
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; 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients colon cancer after completed oxaliplatin-containing chemotherapy regimen post complete surgical removal of the primary colon tumor
MedDRA version: 9.1 Level: LLT Classification code 10009944 Term: Colon cancer

Intervention(s)

Product Name: Xaliproden
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: Buccal use

Primary Outcome(s)

Secondary Objective: To assess the effect 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 effects of xaliproden on the time to complete recovery from PSN To evaluate the safety profile of xaliproden

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, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Primary end point(s): Ratio of Patient's PSN complete resolution 6 months after completion of FOLFOX4.

Secondary ID(s)

2007-000945-36-FR

XALIP_C_02090