Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603577
Recruitment Status : Terminated (development of product discontinued)
First Posted : January 29, 2008
Last Update Posted : May 5, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Placebo Drug: Xaliproden Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

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

Primary Outcome Measures :
  1. Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0) [ Time Frame: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits ]

Secondary Outcome Measures :
  1. FACT/GOG NTX-12 subscale [ Time Frame: AT inclusion and subsequently monthly until month 12 ]
  2. Hematological and biochemical testing [ Time Frame: At inclusion, 3 & 6 months ]
  3. AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1) [ Time Frame: During the whole study period (including follow-up) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603577

Layout table for location information
United States, New Jersey
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
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Jean-Philippe Aussel Sanofi
Layout table for additonal information
Responsible Party: Sanofi Identifier: NCT00603577    
Other Study ID Numbers: XALIP_C_02090
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs