Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens (XENON)
Primary Purpose
Colorectal Neoplasms
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Xaliproden
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Xaliproden
Arm Description
Outcomes
Primary Outcome Measures
Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)
Secondary Outcome Measures
FACT/GOG NTX-12 subscale
Hematological and biochemical testing
AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00603577
Brief Title
Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
Acronym
XENON
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
development of product discontinued
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Xaliproden
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
Intervention Type
Drug
Intervention Name(s)
Xaliproden
Intervention Description
1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
FACT/GOG NTX-12 subscale
Time Frame
AT inclusion and subsequently monthly until month 12
Title
Hematological and biochemical testing
Time Frame
At inclusion, 3 & 6 months
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Aussel
Organizational Affiliation
Sanofi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Québec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Frankfurt
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Kallithea
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Milan
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
We'll reach out to this number within 24 hrs