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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006246-33 | EudraCT Number | ||
| U1111-1127-0888 | Other Identifier | UTN |
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The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.
The Treatment Extension protocol consists of three time points/periods: the Screening Period (during which assessments are performed to determine whether the patient meets the criteria to participate in the study), the Treatment Period (during which the patient receives treatment with the study drug(s)), and the Post-Treatment Period (during which patients complete an evaluation approximately 30 days after the last dose of study drug). Patients may continue to participate on the Treatment Extension study as long as they meet criteria to continue to receive therapy, tolerate the treatment regimen, do not develop progressive disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib becomes commercially available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iniparib (SAR240550/BSI-201) | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with incidence of adverse events by NCI-CTCAE version 4.03 | Up to 30 days after last treatment dose |
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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 840013 | Birmingham | Alabama | 35205 | United States | ||
| Investigational Site Number 840033 |
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| Carboplatin |
| Drug |
Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Doxorubicin HCL liposome injection | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Gemcitabine | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Irinotecan | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Paclitaxel | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Topotecan | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Santa Maria |
| California |
| 93454-8903 |
| United States |
| Investigational Site Number 840046 | Vallejo | California | 94589 | United States |
| Investigational Site Number 840008 | Denver | Colorado | 80218 | United States |
| Investigational Site Number 840027 | Jacksonville | Florida | 32256 | United States |
| Investigational Site Number 840063 | Augusta | Georgia | 30912 | United States |
| Investigational Site Number 840055 | Tucker | Georgia | 30084 | United States |
| Investigational Site Number 840039 | Maywood | Illinois | 60153 | United States |
| Investigational Site Number 840012 | Indianapolis | Indiana | 46227 | United States |
| Investigational Site Number 840025 | Sioux City | Iowa | 51105 | United States |
| Investigational Site Number 840030 | Boston | Massachusetts | 02115 | United States |
| Investigational Site Number 840001 | Detroit | Michigan | 48201 | United States |
| Investigational Site Number 840006 | Minneapolis | Minnesota | 55407-3799 | United States |
| Investigational Site Number 840002 | Jackson | Mississippi | 39202 | United States |
| Investigational Site Number 840059 | St Louis | Missouri | 63110 | United States |
| Investigational Site Number 840004 | St Louis | Missouri | 63141 | United States |
| Investigational Site Number 840022 | Las Vegas | Nevada | 89169 | United States |
| Investigational Site Number 840017 | Voorhees Township | New Jersey | 08043 | United States |
| Investigational Site Number 840010 | Albany | New York | 12206 | United States |
| Investigational Site Number 840015 | Charlotte | North Carolina | United States |
| Investigational Site Number 840060 | Cincinnati | Ohio | United States |
| Investigational Site Number 840043 | Cleveland | Ohio | 44106 | United States |
| Investigational Site Number 840021 | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigational Site Number 840028 | Memphis | Tennessee | 38120-2146 | United States |
| Investigational Site Number 840007 | Austin | Texas | 78731 | United States |
| Investigational Site Number 840003 | El Paso | Texas | 79915 | United States |
| Investigational Site Number 840019 | Plano | Texas | 75075 | United States |
| Investigational Site Number 840005 | Norfolk | Virginia | 23502 | United States |
| Investigational Site Number 840009 | Vancouver | Washington | 98684 | United States |
| Investigational Site Number 056002 | Leuven | 3000 | Belgium |
| Investigational Site Number 380002 | Genova | 16132 | Italy |
| Investigational Site Number 724001 | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| C090712 | iniparib |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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