Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

NCT ID: NCT00603577

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-11-30

Brief Summary

Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Secondary objective:

• To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (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

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

Xaliproden

Group Type: EXPERIMENTAL

Xaliproden

Intervention Type: DRUG

1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

Interventions

Placebo

Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

Intervention Type: DRUG

Xaliproden

1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
• Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
• Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 x upper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (c)HbA1c ≤7%; (d) neutrophils ≥1.5x10^9/L ; (e) platelets ≥50x10^9/L; (f) Serum D-dimer within normal limits

Exclusion Criteria

• Pre-existing peripheral neuropathy prior to treatment with oxaliplatin
• Receiving any further anti-cancer treatment
• History of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
• Unstable cardiac disease
• History of significant neurological or psychiatric disorders including dementia or seizures,
• Active uncontrolled infection
• Active disseminated intravascular coagulation
• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
• 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
• Concurrent treatment with any other experimental drugs
• Pregnant or breast-feeding women;
• 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
• 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Aussel

Role: PRINCIPAL_INVESTIGATOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Québec, , Canada

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Frankfurt, , Germany

Sanofi-Aventis Administrative Office

Kallithea, , Greece

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Guildford Surrey, , United Kingdom

Countries

United States; Canada; France; Germany; Greece; Italy; Spain; United Kingdom

Other Identifiers

XALIP_C_02090

Identifier Type: -

Identifier Source: org_study_id