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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast

Outcome Time Frame:

predose and up to 24 hours post dose on Days -1, 1, 15 and 16

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

INT12497

NCT ID:

NCT01585623

Start Date:

June 2012

Completion Date:

March 2013

Related Keywords:

  • Solid Tumor
  • Neoplasms

Name

Location

Investigational Site Number 840001Detroit, Michigan  48201
Investigational Site Number 840002Philadelphia, Pennsylvania  19111
Investigational Site Number 840004Augusta, Georgia  30912