Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(development of product discontinued)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00603577
First received: January 17, 2008
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

Primary 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.

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

Condition Intervention Phase
Colorectal Neoplasms
Drug: placebo
Drug: xaliproden
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Neurological sensory assessment using the NCI-CTCAE (Version 3.0) [ Time Frame: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FACT/GOG NTX-12 subscale [ Time Frame: AT inclusion and subsequently monthly until month 12 ] [ Designated as safety issue: No ]
  • Hematological and biochemical testing [ Time Frame: At inclusion, 3 & 6 months ] [ Designated as safety issue: No ]
  • AE graded with NCI CTAE (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) ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: placebo
placebo
Experimental: 1 Drug: xaliproden
1.0 mg capsule or matching placebo. One capsule of investigational product (IP) daily for 6 months or until resolution of PSN (whichever comes first).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ECOG Performance Status ≤2;
  • Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 ULN; (b) serum creatinine ≤1.5xUNL; (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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603577

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Canada
Sanofi-Aventis Administrative Office
Québec, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Greece
Sanofi-Aventis Administrative Office
Kallithea, Greece
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Jean-Philippe Aussel Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis groupe
ClinicalTrials.gov Identifier: NCT00603577     History of Changes
Other Study ID Numbers: XALIP_C_02090
Study First Received: January 17, 2008
Last Updated: January 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014