Trial record 1 of 1 for:    INT12497
Previous Study | Return to List | Next Study

Drug Interaction Study of SAR302503 in Patients With Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01585623
First received: April 13, 2012
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Solid Tumor
Drug: SAR302503
Drug: omeprazol
Drug: metoprolol
Drug: midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast [ Time Frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24 [ Time Frame: Day-1 to Day 16 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2) [ Time Frame: up to 2 cycles ( i.e. 10 weeks) ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585623

Locations
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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01585623     History of Changes
Other Study ID Numbers: INT12497, U1111-1125-8930
Study First Received: April 13, 2012
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Metoprolol
Metoprolol succinate
Midazolam
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Central Nervous System Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators

ClinicalTrials.gov processed this record on August 27, 2014