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Drug Interaction Study of SAR302503 in Patients With Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585623
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : March 22, 2013
Information provided by (Responsible Party):

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: SAR302503 Drug: omeprazol Drug: metoprolol Drug: midazolam Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Segment 1
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
Drug: SAR302503

Pharmaceutical form:capsule

Route of administration: oral

Drug: omeprazol

Pharmaceutical form:capsule

Route of administration: oral

Drug: metoprolol

Pharmaceutical form:tablet

Route of administration: oral

Drug: midazolam

Pharmaceutical form:solution

Route of administration: oral

Experimental: Segment 2
SAR302503 500 mg once daily without food in 28-day per cycle
Drug: SAR302503

Pharmaceutical form:capsule

Route of administration: oral

Primary Outcome Measures :
  1. Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast [ Time Frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16 ]

Secondary Outcome Measures :
  1. Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter : Cmax, Tmax, and t1/2z [ Time Frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16 ]
  2. SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24 [ Time Frame: Day-1 to Day 16 ]
  3. Clinical and laboratory events graded by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 (Segment 1 and 2) [ Time Frame: up to maximum 2 years ]
  4. Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2) [ Time Frame: up to 2 cycles ( i.e. 10 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist
  • Signed informed consent

Exclusion criteria:

  • Less than 18 years of age.
  • Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
  • Inability to follow study requirements and schedule
  • Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy
  • Serious medical illness at same time of study and/or significantly abnormal lab reports
  • Lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
  • Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
  • Continued toxic effects of prior chemotherapy
  • Evidence of other concurrent active malignancy
  • Other concurrent serious illness or medical condition
  • Cardiac abnormalities include bradycardia, AV block or other conduction defect on ECG, and patients taking a beta blocker.
  • Patients with Insulin-Dependent Diabetes Mellitus.
  • Patients with known active (acute or chronic) hepatitis A, B, C, and hepatitis B and C carries. Prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]).
  • Inadequate organ function
  • History of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01585623

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United States, Georgia
Investigational Site Number 840004
Augusta, Georgia, United States, 30912
United States, Michigan
Investigational Site Number 840001
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Investigational Site Number 840002
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Identifier: NCT01585623    
Other Study ID Numbers: INT12497
U1111-1125-8930 ( Other Identifier: UTN )
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents