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| ID | Type | Description | Link |
|---|---|---|---|
| 20100109 | Other Identifier | BiPar |
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This is a Phase 1, multi-center, open-label study.
During Segment 1, patients are administered a single IV administration of [14C]-iniparib.
During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iniparib | Experimental | Segment 1: 400 mg [14C]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iniparib | Drug | Solution for infusion 60-minute intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib | Up to 35 days | |
| The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity | up to 35 days | |
| The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration | 96 hours | |
| The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. | Up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical and biological tolerability of iniparib. | During treatment and until 30 days post treatment |
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Male or female patients with advanced solid tumors that are refractory to standard treatment or for which no standard treatment exists; patients must be at least 18 years old.
Additional criteria are also required and should be evaluated by the research staff.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
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| ID | Term |
|---|---|
| C090712 | iniparib |
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