Clinical trials: sponsored by Sanofi
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Trial name
- NCT01812707
- Testing
- Alirocumab, Atorvastatin
- Where
- 4 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Sanofi
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
Hypercholesterolaemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01617655
- Testing
- Alirocumab, Lipid Modifying Therapy (LMT)
- Where
- 35 sites in United States, Canada and 3 more
- Volunteers
- 107 people
- Sponsor
- Sanofi
Non-small Cell Lung Cancer, Lung Cancer
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC).
- Trial name
- ZODIAC (NCT00312377)
- Testing
- Docetaxel, Vandetanib
- Where
- 156 sites in United States, Argentina and 23 more
- Volunteers
- 1,690 people
- Sponsor
- Genzyme, a Sanofi Company
Advanced Breast Cancer
E3 Breast Cancer Taxotere Combination
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
- Trial name
- NCT00494481
- Testing
- Vandetanib (ZD6474), Docetaxel
- Where
- 12 sites in Hungary, South Africa and 3 more
- Volunteers
- 64 people
- Sponsor
- Genzyme, a Sanofi Company
Non-Small-Cell Lung Carcinoma
ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred…
- Trial name
- NCT00404924
- Testing
- ZD6474 (vandetanib), Best Supportive Care
- Where
- 102 sites in United States, Argentina and 20 more
- Volunteers
- 1,140 people
- Sponsor
- Genzyme, a Sanofi Company
Hypercholesterolemia
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Primary Objective: To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).
- Trial name
- NCT01723735
- Testing
- Alirocumab, Ezetimibe, Fenofibrate
- Where
- 2 sites in France
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hypercholesterolemia
Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
Primary Objective: To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
- Trial name
- NCT01448317
- Testing
- Alirocumab (Solution), Alirocumab (Lyophilized formulation)
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia
Primary Objective: To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia.
- Trial name
- NCT02635243
- Testing
- SAR438544, r-glucagon, insulin
- Sponsor
- Sanofi
Advanced Solid, Malignant Tumors
Phase I Chinese PK
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
- Trial name
- NCT00503711
- Testing
- Vandetanib, Vandetanib 300 mg
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Medullary Thyroid Cancer
Vandetanib Risk Minimisation Effectiveness
Effectiveness of risk minimisation interventions for vandetanib in Canada
- Trial name
- NCT01757470
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Non-small Cell Lung Cancer (NSCLC)
Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases
A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy.
- Trial name
- NCT00807170
- Testing
- ZD6474 (Vandetanib), Whole Brain Radiotherapy (WBRT), ZD6474
- Where
- 3 sites in Netherlands
- Volunteers
- 5 people
- Sponsor
- Sanofi
Pancreatic Cancer
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
- Trial name
- NCT00681798
- Testing
- Vandetanib
- Where
- 2 sites in Switzerland
- Volunteers
- 8 people
- Sponsor
- Sanofi
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior…
- Trial name
- ECO-1 (NCT00206726)
- Testing
- Alemtuzumab plus Fludarabine
- Where
- 27 sites in United States
- Volunteers
- 60 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy
A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib
- Trial name
- Vandetanib (NCT01551615)
- Testing
- Metformin 1000 mg, Vandetanib 800 mg
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers
Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
- Trial name
- Vandetanib (NCT01544140)
- Testing
- Midazolam, vandetanib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers
Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib
This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.
- Trial name
- Vandetanib (NCT01561781)
- Testing
- Digoxin, Vandetanib
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sanofi
Head and Neck Cancer
Open Label, Phase I ZD6474 Head and Neck Cancer Study
The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.
- Trial name
- NCT00450138
- Testing
- ZD6474 (vandetanib), Cisplatin, Radiation
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Sanofi
Non Small Cell Lung Cancer
Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC
To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell…
- Trial name
- NCT00496275
- Testing
- Zactima (ZD6474), Vinorelbine plus cisplatin, Gemcitabine plus cisplatin
- Volunteers
- 17 people
- Sponsor
- Genzyme, a Sanofi Company
Colorectal Cancer
Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer
A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability In Patients with Advanced Colorectal Cancer and Liver Metastases.
- Trial name
- NCT00496509
- Testing
- ZD6474 (Zactima) 100mg, Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR), Biomarker Draws
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company