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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Neurological sensory assessment using the NCI-CTCAE (Version 3.0)

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jean-Philippe Aussel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

XALIP_C_02090

NCT ID:

NCT00603577

Start Date:

January 2008

Completion Date:

November 2009

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Sanofi-Aventis Administrative Office Bridgewater, New Jersey  08807