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Xaliproden

Phase 3

Metastases | Small molecule | Oncology |Sanofi|Last Updated: May 4, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment879

FDA Designations

No designations recorded

Clinical trial landscape

Xaliproden · 3 trials · 4 indications

Phase 3 3
NCT00305188Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.Metastases
COMPLETED879 Analytics
NCT0010364918-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's TypeAlzheimer Disease
COMPLETED1,306 Analytics
NCT00104013Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's TypeAlzheimer Disease
COMPLETED1,455 Analytics
PHASE3COMPLETED
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
MetastasesUnlock trial analytics
PHASE3COMPLETED
18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Alzheimer DiseaseUnlock trial analytics
PHASE3COMPLETED
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Q2W during treatment, Q4W to Q12W during post-treatment follow-up
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary Endpoints

Main: response rate using RECIST criteria
Q8W
Other: nerve conduction studies
baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Q8W and study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Xaliproden (SR57746A)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Xaliproden (SR57746A)DRUGoral administration
PlaceboDRUGoral administration
OxaliplatinDRUGIV administration
5-FluorouracilDRUGIV administration
LeucovorinDRUGIV administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: Main inclusion criteria : * Histologically or cytologically-proven metastatic cancer of the colon or rectum. * Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease). * Male or female aged \>18 years. * WHO Performance Status (PS) ...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileGermanyHungaryItalyPolandPortugalSpainUnited KingdomFranceHong KongNetherlandsSingaporeSouth AfricaTaiwan
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Frequently asked questions about Xaliproden

What is Xaliproden used for?

Xaliproden is an investigational small molecule studied for Alzheimer disease and for preventing neurotoxicity from oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer. It was evaluated in Phase 3 clinical trials for both indications. The drug is not approved and remains in clinical development.

Who makes Xaliproden?

Xaliproden is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi sponsored the Phase 3 clinical trials of Xaliproden in Alzheimer disease and in metastatic colorectal cancer patients receiving chemotherapy.

What phase is Xaliproden in?

Xaliproden has completed Phase 3 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. The completed Phase 3 studies evaluated its efficacy in Alzheimer disease and in preventing chemotherapy-induced neurotoxicity in metastatic colorectal cancer.

What clinical trials is Xaliproden in?

Xaliproden has completed three Phase 3 trials. NCT00103649 and NCT00104013 studied the drug in patients with mild-to-moderate Alzheimer disease. NCT00305188 evaluated Xaliproden for preventing neurotoxicity of oxaliplatin/5FU/LV chemotherapy in patients with metastatic colorectal cancer. All trials are completed.

Is Xaliproden the same as SR57746A?

Yes, Xaliproden is also known as SR57746A. Clinical trial records refer to the drug by both names, for example in the Phase 3 studies of Xaliproden (SR57746A) in Alzheimer disease and in chemotherapy-induced neurotoxicity prevention.

How does Xaliproden work?

Xaliproden is a small molecule designed to provide neuroprotective effects. In clinical trials, it was studied for its potential to slow cognitive decline in Alzheimer disease and to protect nerves from damage caused by oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer.