Drug Interaction Study of SAR302503 in Patients With Solid Tumor
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | June 2012 |
| End Date: | November 2012 |
| Contact: | For site information, send an email with site number to |
| Email: | Contact-Us@sanofi-aventis.com |
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
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.
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.
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