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two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days

SAR302503 500 mg once daily without food in 28-day per cycle

Pharmaceutical form:capsule

Route of administration: oral

SAR302503

omeprazol

Pharmaceutical form:tablet

Route of administration: oral

metoprolol

Pharmaceutical form:solution

Route of administration: oral

midazolam

Clinical Sciences & Operations

Primary Objective:

* To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).
* To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.

Secondary Objectives:

* To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1
* To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2
* To determine antitumor activity in Segment 2

The duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.

Drug Interaction Study of SAR302503 in Patients With Solid Tumor

An Open-label, Two-treatment Crossover Pharmacokinetic Interaction Study of Repeated Doses of SAR302503 on Pharmacokinetics of a Single Dose Cocktail of Omeprazole, Metoprolol, and Midazolam Used as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 Activities, Respectively in Adult Patients With Refractory Solid Tumors

Sanofi

Neoplasms

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Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Arrhythmias, Cardiac

Heart Diseases

Vasoconstrictor Agents

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Losartan

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Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Daniela Cardinale, MD

The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative period.

Postoperative atrial fibrillation is one of the most common complication after thoracic surgery for lung cancer, with an incidence ranging from 8 to 20% after lobectomy and up to 42% after pneumonectomy.

In a recent study we demonstrated that a high perioperative plasma levels of NT-proBNP is able to identify patients at risk for AF (incidence of 65%).

It has also been demonstrated that the renin-angiotensin system may play an important role in the pathophysiology of atrial fibrillation and that angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARBs) are able to prevent atrial fibrillation in patients with heart failure, after myocardial infarction, in hypertensive patients and after electrical cardioversion.

PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer

Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

European Institute of Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Drug Interaction Study of SAR302503 in Patients With Solid Tumor	NCT01585623	Solid Tumor	SAR302503 omeprazol metoprolol midazolam	18 Years -	Sanofi
PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer	NCT01281787	Lung Cancer Atrial Fibrilla...	Metoprolol Losartan	18 Years -	European Institute of Oncology

Spots Global Cancer Trial Database for metoprolol

Every month we try and update this database with for metoprolol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for metoprolol

Every month we try and update this database with for metoprolol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for metoprolol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.