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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel/carboplatin with custirsen | Experimental | Custirsen added to standard paclitaxel/carboplatin chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custirsen, paclitaxel and carboplatin | Drug | Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the impact of custirsen on paclitaxel pharmacokinetics | The maximum peak concentration of paclitaxel after administration. | 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy | 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 002 | Detroit | Michigan | United States | |||
| Teva Investigational Site 001 |
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|
| Dallas |
| Texas |
| United States |
| Teva Investigational Site 003 | San Antonio | Texas | United States |
| Teva Investigational Site 004 | Tacoma | Washington | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C503781 | OGX-011 |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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