Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Dow
Baxter
Johnson and Johnson
Medtronic
Harvard Business School
Mallinckrodt

Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR PSN-632,408


✉ Email this page to a colleague

« Back to Dashboard

Clinical Trials for PSN-632,408

Trial ID Title Status Sponsor Phase Summary
NCT00305188 ↗ Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy. Completed Sanofi Phase 3 Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
NCT00603577 ↗ Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens Terminated Sanofi Phase 3 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
NCT01087658 ↗ Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity Completed Sanofi Phase 3 Primary Objective: To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred. Secondary Objective: To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN. To determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4. To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale. To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for PSN-632,408

Condition Name

Condition Name for
Intervention Trials
Colorectal Neoplasms 3
Chronic Myeloid Leukemia 1
Colorectal Carcinoma 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for
Intervention Trials
Colorectal Neoplasms 3
Neurotoxicity Syndromes 2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for PSN-632,408

Trials by Country

Trials by Country for
Location Trials
Canada 4
Italy 3
Germany 2
United Kingdom 2
Greece 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for
Location Trials
New Jersey 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for PSN-632,408

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
N/A 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Terminated 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for PSN-632,408

Sponsor Name

Sponsor Name for
Sponsor Trials
Sanofi 3
Attikon Hospital 1
National Cheng-Kung University Hospital 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for
Sponsor Trials
Other 7
Industry 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Boehringer Ingelheim
Express Scripts
Harvard Business School
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.