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Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens (XENON)
This study is currently recruiting participants.
Verified by Sanofi-Aventis, December 2008
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00603577
  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 III

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Oxaliplatin Xaliproden SR 57746A
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment: 244
Study Start Date: January 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Placebo Comparator Drug: placebo
placebo
1: Experimental 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603577

Contacts
Contact: PUBLIC REGISTRY GMA PUBLICREGISTRYGMA@sanofi-aventis.com

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

Responsible Party: sanofi-aventis groupe ( Medical Affairs Study Director )
Study ID Numbers: XALIP_C_02090
Study First Received: January 17, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00603577  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009