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This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug | |||
| Dexamethasone | Drug | |||
| Ondansetron Hydrochloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19834961 | Result | Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009 Dec 15;115(24):5807-16. doi: 10.1002/cncr.24630. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 8, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Corona |
| California |
| 92882 |
| United States |
| GSK Investigational Site | Greenbrae | California | 94904-2007 | United States |
| GSK Investigational Site | Loma Linda | California | 92354 | United States |
| GSK Investigational Site | Los Angeles | California | 90057 | United States |
| GSK Investigational Site | Palm Springs | California | 92262 | United States |
| GSK Investigational Site | Lakewood | Colorado | 80215 | United States |
| GSK Investigational Site | Boynton Beach | Florida | 33435 | United States |
| GSK Investigational Site | Hudson | Florida | 34667 | United States |
| GSK Investigational Site | Miami | Florida | 33138 | United States |
| GSK Investigational Site | Ocala | Florida | 34474 | United States |
| GSK Investigational Site | Centralia | Illinois | 62801 | United States |
| GSK Investigational Site | Park Ridge | Illinois | 60068 | United States |
| GSK Investigational Site | Skokie | Illinois | 60076 | United States |
| GSK Investigational Site | Evansville | Indiana | 47713 | United States |
| GSK Investigational Site | Muncie | Indiana | 47303 | United States |
| GSK Investigational Site | New Albany | Indiana | 47150 | United States |
| GSK Investigational Site | Hutchinson | Kansas | 67502 | United States |
| GSK Investigational Site | Alexandria | Louisiana | 71301 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20817 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01608 | United States |
| GSK Investigational Site | Bay City | Michigan | 48708 | United States |
| GSK Investigational Site | Tupelo | Mississippi | 38801 | United States |
| GSK Investigational Site | Jefferson City | Missouri | 65109 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Sparta | New Jersey | 07871 | United States |
| GSK Investigational Site | Rochester | New York | 14621 | United States |
| GSK Investigational Site | The Bronx | New York | 10467-2490 | United States |
| GSK Investigational Site | Bismarck | North Dakota | 58503 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Sumter | South Carolina | 29150 | United States |
| GSK Investigational Site | Corpus Christi | Texas | 78463-3069 | United States |
| GSK Investigational Site | Dallas | Texas | 75237 | United States |
| GSK Investigational Site | Houston | Texas | 77024 | United States |
| GSK Investigational Site | Tyler | Texas | 75708 | United States |
| GSK Investigational Site | Ogden | Utah | 84403 | United States |
| GSK Investigational Site | West Point | Utah | 84341 | United States |
| GSK Investigational Site | Burlington | Vermont | 05401 | United States |
| GSK Investigational Site | Abingdon | Virginia | 24211 | United States |
| GSK Investigational Site | Richmond | Virginia | 23230 | United States |
| GSK Investigational Site | Everett | Washington | 98201 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Tacoma | Washington | 98431 | United States |
| GSK Investigational Site | Rhinelander | Wisconsin | 54501 | United States |
| GSK Investigational Site | Capital Federal | Buenos Aires | C1437JCP | Argentina |
| GSK Investigational Site | Buenos Aires | C1405CBA | Argentina |
| GSK Investigational Site | Salzburg | A-5020 | Austria |
| GSK Investigational Site | Vienna | A-1090 | Austria |
| GSK Investigational Site | Vienna | A-1130 | Austria |
| GSK Investigational Site | Kitchener | Ontario | N2G 1G3 | Canada |
| GSK Investigational Site | Oshawa | Ontario | L1G 2B9 | Canada |
| GSK Investigational Site | Charlottetown | Prince Edward Island | C1A 8T5 | Canada |
| GSK Investigational Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| GSK Investigational Site | Québec | Quebec | G1J 1Z4 | Canada |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500921 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 8380456 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
| GSK Investigational Site | Osijek | Croatia |
| GSK Investigational Site | Hradec Králové | 500 05 | Czechia |
| GSK Investigational Site | Ostrava - Poruba | 708 52 | Czechia |
| GSK Investigational Site | Prague | 100 00 | Czechia |
| GSK Investigational Site | Prague | 154 00 | Czechia |
| GSK Investigational Site | Prague | 180 00 | Czechia |
| GSK Investigational Site | Munich | Bavaria | 81675 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93049 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Athens | 115 22 | Greece |
| GSK Investigational Site | Haidari | 124 61 | Greece |
| GSK Investigational Site | Thessaloniki | 564 29 | Greece |
| GSK Investigational Site | Pokfulam | Hong Kong |
| GSK Investigational Site | Budapest | 1529 | Hungary |
| GSK Investigational Site | Mátraháza | 3233 | Hungary |
| GSK Investigational Site | Dublin | 4 | Ireland |
| GSK Investigational Site | Dublin | 7 | Ireland |
| GSK Investigational Site | Dublin | 8 | Ireland |
| GSK Investigational Site | Dublin | 9 | Ireland |
| GSK Investigational Site | Tallaght, Dublin | 24 | Ireland |
| GSK Investigational Site | Tullamore | Ireland |
| GSK Investigational Site | Durango | Durango | 34000 | Mexico |
| GSK Investigational Site | Mérida | Yucatán | 97500 | Mexico |
| GSK Investigational Site | Karachi | 54000 | Pakistan |
| GSK Investigational Site | Lahore | Pakistan |
| GSK Investigational Site | Quezon City | 1101 | Philippines |
| GSK Investigational Site | Taft Avenue, Manila | 1700 | Philippines |
| GSK Investigational Site | Kielce | 25-640 | Poland |
| GSK Investigational Site | Olsztyn | 10-228 | Poland |
| GSK Investigational Site | Opole | 45-060 | Poland |
| GSK Investigational Site | Szczecin | 71-730 | Poland |
| GSK Investigational Site | Lisbon | 1070 | Portugal |
| GSK Investigational Site | Moscow | 115 478 | Russia |
| GSK Investigational Site | Moscow | 117997 | Russia |
| GSK Investigational Site | Moscow | 129301 | Russia |
| GSK Investigational Site | Moscow Region | 143 423 | Russia |
| GSK Investigational Site | Singapore | 169610 | Singapore |
| GSK Investigational Site | Bratislava | 833 10 | Slovakia |
| GSK Investigational Site | Žilina | 010 01 | Slovakia |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Marid | 28040 | Spain |
| GSK Investigational Site | Pontevedra | 36071 | Spain |
| GSK Investigational Site | Valencia | 46009 | Spain |
| GSK Investigational Site | Tainan | 704 | Taiwan |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 104 | Taiwan |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Chiang Mai | 50200 | Thailand |
| GSK Investigational Site | Exeter | Devon | EX2 5DW | United Kingdom |
| GSK Investigational Site | Chelmsford | Essex | CM1 7ET | United Kingdom |
| GSK Investigational Site | Cardiff | Glamorgan | CF14 2TL | United Kingdom |
| GSK Investigational Site | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| GSK Investigational Site | Shrewsbury | SY3 8XQ | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 8, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531951 | casopitant |
| D003907 | Dexamethasone |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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