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

NCT00603577 | Terminated Phase 3 DMC

• 1 other identifier: XALIP_C_02090
• Study Type: interventional
• Target: 102
• Locations: 8 countries
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)

  inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits

Secondary Outcomes (3)

• FACT/GOG NTX-12 subscale

  AT inclusion and subsequently monthly until month 12

• Hematological and biochemical testing

  At inclusion, 3 & 6 months

• AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)

  During the whole study period (including follow-up)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Xaliproden

EXPERIMENTAL

Drug: Xaliproden

Interventions

Placebo DRUG

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

Placebo

Xaliproden DRUG

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

Xaliproden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Location

Sanofi-Aventis Administrative Office

Québec, Canada

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Frankfurt, Germany

Location

Sanofi-Aventis Administrative Office

Kallithea, Greece

Location

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

Sanofi-Aventis Administrative Office

Guildford Surrey, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

xaliproden

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jean-Philippe Aussel

  Sanofi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 5, 2016

Record last verified: 2016-04

Locations

CA (1); GB (1); DE (1); US (1); FR (1); ES (1); GR (1); IT (1)