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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Pharmaceutical form:capsule Route of administration: oral
Pharmaceutical form:capsule Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Investigational Site Number 840004
Augusta, Georgia, United States
Investigational Site Number 840001
Detroit, Michigan, United States
Investigational Site Number 840002
Philadelphia, Pennsylvania, United States
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast
Time frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16
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
SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24
Time frame: Day-1 to Day 16
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
Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2)
Time frame: up to 2 cycles ( i.e. 10 weeks)
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Pharmaceutical form:solution Route of administration: oral