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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1125-8930 | Other Identifier | UTN |
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Primary Objective:
Secondary Objectives:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Segment 1 | Experimental | 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 |
|
| Segment 2 | Experimental | SAR302503 500 mg once daily without food in 28-day per cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR302503 | Drug | Pharmaceutical form:capsule Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast | predose and up to 24 hours post dose on Days -1, 1, 15 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter : Cmax, Tmax, and t1/2z | predose and up to 24 hours post dose on Days -1, 1, 15 and 16 | |
| SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24 | Day-1 to Day 16 |
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Inclusion criteria :
Exclusion criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840004 | Augusta | Georgia | 30912 | United States | ||
| Investigational Site Number 840001 |
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| ID | Term |
|---|---|
| C528327 | fedratinib |
| D009853 | Omeprazole |
| D008790 | Metoprolol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| omeprazol | Drug | Pharmaceutical form:capsule Route of administration: oral |
|
| metoprolol | Drug | Pharmaceutical form:tablet Route of administration: oral |
|
| midazolam | Drug | Pharmaceutical form:solution Route of administration: oral |
|
| Clinical and laboratory events graded by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 (Segment 1 and 2) | up to maximum 2 years |
| Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2) | up to 2 cycles ( i.e. 10 weeks) |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Investigational Site Number 840002 | Philadelphia | Pennsylvania | 19111 | United States |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |