Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Oxaliplatin/5-FU/LV and PTK787/ZK 222584 |
Drug: Vatalanib
Other Names:
|
Placebo Comparator: 2 Oxaliplatin/5-FU/LV and placebo |
Drug: Vatalanib
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival [throughout duration of study]
Secondary Outcome Measures
- Progression free survival [throughout duration of study]
- Time to progression [throughout duration of study]
- Time to treatment failure [throughout duration of study]
- Tumor response rate [throughout duration of study]
- Tolerability and safety profile [throughout duration of study]
Eligibility Criteria
Criteria
Inclusion criteria
-
Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
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One prior chemotherapy regimen with irinotecan and 5FU
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Evidence of progressive disease within 6 months after last dose of irinotecan
-
WHO Performance Status of 0, 1, or 2
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Measurable tumors
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Adequate hematologic status, liver and kidney function
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Life expectancy greater than 12 weeks
-
Written informed consent obtained
Exclusion criteria
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History or presence of central nervous system disease
-
Patients with a history of another primary cancer within 5 years
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Prior chemotherapy within 3 weeks before entry to study
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Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
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Investigational drugs within 4 weeks before entry to study
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Prior therapy with oxaliplatin
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Peripheral neuropathy with functional impairment
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Female patients who are pregnant or breast feeding
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Any severe or uncontrolled medical condition which could prevent participation in study
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Chronic kidney disease
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Acute or chronic liver disease
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Patients taking Coumadin
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Comprehensive Cancer Institute | Huntsville | Alabama | United States | 35801 |
2 | Alaska Oncology and Hematology | Anchorage | Alaska | United States | 99508 |
3 | Arizona Clinical Research Center | Tucson | Arizona | United States | 85712 |
4 | Northeast Arkansas Clinic | Jonesboro | Arkansas | United States | 72401 |
5 | Arkansas Cancer Research Center | Little Rock | Arkansas | United States | 72205 |
6 | Little Rock Hematology & Oncology | Little Rock | Arkansas | United States | 72205 |
7 | Highlands Oncology Group | Springdale | Arkansas | United States | 72764 |
8 | Comprehensive Blood and Cancer Center | Bakersfield | California | United States | 93309 |
9 | Providence St. Joseph Medical Center | Burbank | California | United States | 91505 |
10 | Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | United States | 92708 |
11 | California Oncology of the Central Valley | Fresno | California | United States | 93710 |
12 | Virginia K. Crosson Cancer Center | Fullerton | California | United States | 92835 |
13 | Glendale Adventist Medical Center | Glendale | California | United States | 91206 |
14 | Scripps Green Hospital | La Jolla | California | United States | 92037 |
15 | Wilshire Oncology Medical Group | La Verne | California | United States | 91767 |
16 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
17 | USC Norris Cancer Center | Los Angeles | California | United States | 90033 |
18 | Synergy Hematology-Oncology Medical Associates | Los Angeles | California | United States | 90036 |
19 | Novartis Investigative Site | Los Angeles | California | United States | 90095 |
20 | UCLA School of Medicine | Los Angeles | California | United States | 90095 |
21 | Eddie Hong-Lung Hu, M.D. | Monterey Park | California | United States | 91754 |
22 | North Valley Hematology/Oncology Medical Group | Northridge | California | United States | 91328 |
23 | Medical Oncology Care Associates | Orange | California | United States | 92868 |
24 | Ventura County Hematology-Oncology Specialists | Oxnard | California | United States | 93030 |
25 | Sierra View District Hospital | Porterville | California | United States | 93257 |
26 | Cancer Care Associates Medical Group, Inc. | Redondo Beach | California | United States | 90277 |
27 | Santa Clara Valley Medical Center | San Jose | California | United States | 95128 |
28 | Sansum Santa Barbara Foundation Medical Clinic | Santa Barbara | California | United States | 93105 |
29 | Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | United States | 93105 |
30 | San Diego Cancer Center Medical Group | Vista | California | United States | 92083 |
31 | Mile High Oncology | Denver | Colorado | United States | 80210 |
32 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80220 |
33 | Manchester Hematology/Oncology Assoc. | Manchester | Connecticut | United States | 06040 |
34 | Washington Oncology/Hematology Center | Washington | District of Columbia | United States | 20037 |
35 | The Center for Hematology and Oncology | Boca Raton | Florida | United States | 33486 |
36 | Florida Cancer Specialists | Ft. Myers | Florida | United States | 33901 |
37 | Hematology Oncology Associates | Lake Worth | Florida | United States | 33461-4710 |
38 | University of Miami School of Medicine | Miami | Florida | United States | 33136 |
39 | Oncology/Hematology Group of South Florida | Miami | Florida | United States | 33176 |
40 | Hematology Oncology Associates of Treasure Coast | Port St. Lucie | Florida | United States | 34952 |
41 | Florida Medical Clinic | Zephyrhills | Florida | United States | 33542 |
42 | Atlanta Cancer Care | Marietta | Georgia | United States | 30060 |
43 | Office of Research | Savannah | Georgia | United States | 31405 |
44 | Coastal Hematology & Oncology | Savannah | Georgia | United States | 31406 |
45 | Lewis Hall Singletary Oncology Center | Thomasville | Georgia | United States | 31792 |
46 | North Idaho Cancer Center | Coeur d'Alene | Idaho | United States | 83814 |
47 | University of Chicago medical Center, Hematology/Oncology | Chicago | Illinois | United States | 60637 |
48 | Oncology Hematology Associates of Central Illinois, PC | Peoria | Illinois | United States | 61602 |
49 | Northshore Cancer Research Association | Skokie | Illinois | United States | 60076 |
50 | Midwest Cancer Research Group | Skokie | Illinois | United States | 60077 |
51 | Fort Wayne Medical Oncology & Hematology, Inc. | Fort Wayne | Indiana | United States | 46815 |
52 | Munster Community Hospital | Munster | Indiana | United States | 46321 |
53 | Cotton O'Neil Oncology Clinic | Topeka | Kansas | United States | 66606 |
54 | Vijay Raghaven, M.D. | Louisville | Kentucky | United States | 40215 |
55 | Owensboro Medical Health System | Owensboro | Kentucky | United States | 42303 |
56 | Cabrini Center for Cancer Care | Alexandria | Louisiana | United States | 71301 |
57 | LSU Medical Center | New Orleans | Louisiana | United States | 70112 |
58 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
59 | LSU Health Sciences Center | Shreveport | Louisiana | United States | 71130-3932 |
60 | Maine Center for Cancer Medicine & Blood Disorders | Scarborough | Maine | United States | 04074 |
61 | St. Agnes Healthcare | Baltimore | Maryland | United States | 21229-5299 |
62 | Franklin Square Hospital Center | Baltimore | Maryland | United States | 21237 |
63 | Kaiser Permanente | Rockville | Maryland | United States | 20850 |
64 | Fallon Clinic at Worcester Medical Center | Worcester | Massachusetts | United States | 01605 |
65 | University of Michigan | Ann Arbor | Michigan | United States | 48109-0934 |
66 | Spectrum Health -- Cook Research Dept. | Grand Rapids | Michigan | United States | 49503 |
67 | Providence Cancer Center | Southfield | Michigan | United States | 48075 |
68 | Oncology Care Associates, PLLC | St. Joseph | Michigan | United States | 49085 |
69 | Minnesota CGOP | Minneapolis | Minnesota | United States | 55407 |
70 | Heartland Hematology | Kansas City | Missouri | United States | 64118 |
71 | Missouri Cancer Care, PC | St. Charles | Missouri | United States | 63301 |
72 | Saint Louis University | St. Louis | Missouri | United States | 63110 |
73 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
74 | Missouri Baptist Cancer Center | St. Louis | Missouri | United States | 63131 |
75 | Arch Medical Services Incorporated | St. Louis | Missouri | United States | 63141 |
76 | North Central Montana Professional Building | Great Falls | Montana | United States | 59405 |
77 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89109 |
78 | Nevada Cancer Center | Las Vegas | Nevada | United States | 89109 |
79 | NH Oncology-Hematology, PA | Hooksett | New Hampshire | United States | 03106 |
80 | Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey | United States | 08003 |
81 | St. Barnabas Cancer Center | Livingston | New Jersey | United States | 07039 |
82 | Hematology Oncology Associates of Northern New Jersey | Morristown | New Jersey | United States | 07960 |
83 | Cooper Cancer Center | Voorhees | New Jersey | United States | 08043 |
84 | Hematology/Oncology Associates | Albuquerque | New Mexico | United States | 87102 |
85 | New Mexico Oncology/Hematology | Albuquerque | New Mexico | United States | 87109 |
86 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
87 | Hematology/Oncology Associates of Central NY | East Syracuse | New York | United States | 13057 |
88 | Queens Medical Associates, PC | Fresh Meadows | New York | United States | 11365 |
89 | Charles R. Wood Cancer Center | Glens Falls | New York | United States | 12801 |
90 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
91 | St. Vincent's Catholic Medical Centers of New York | New York | New York | United States | 10011 |
92 | Hematology-Oncology Associates of Rockland | Nyack | New York | United States | 10956 |
93 | Pluta Cancer Center | Rochester | New York | United States | 14623 |
94 | James P. Wilmot Cancer Center | Rochester | New York | United States | 14642 |
95 | Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599-7305 |
96 | Carolinas Hematology/Oncology Associates | Charlotte | North Carolina | United States | 28203 |
97 | Nashat Gabrail, M.D. | Canton | Ohio | United States | 44718 |
98 | Case Western Reserve University | Cleveland | Ohio | United States | 44106-5056 |
99 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
100 | Columbus CCOP | Columbus | Ohio | United States | 43206 |
101 | The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
102 | Oklahoma Oncology, Inc. | Tulsa | Oklahoma | United States | 74104 |
103 | Consultants in Medical Oncology & Hematology | Drexel Hill | Pennsylvania | United States | 19026 |
104 | Hematology & Oncology Associates of NE PA | Dunmore | Pennsylvania | United States | 18512 |
105 | Penn State Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
106 | Monongahela Valley Hospital | Monongahela | Pennsylvania | United States | 15063 |
107 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
108 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212-4772 |
109 | UPMC Cancer Pavillion | Pittsburgh | Pennsylvania | United States | 15232 |
110 | Charleston Cancer Center | Charleston | South Carolina | United States | 29406 |
111 | South Carolina Oncology Associates | Columbia | South Carolina | United States | 29201 |
112 | WJB Dom VAMC | Columbia | South Carolina | United States | 29209 |
113 | Cancer Center of the Carolinas | Greenville | South Carolina | United States | 29615 |
114 | Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
115 | Erlanger Health System | Chattanooga | Tennessee | United States | 37403 |
116 | Clarksville Regional Hematology/Oncology | Clarksville | Tennessee | United States | 37043 |
117 | The Jones Clinic | Germantown | Tennessee | United States | 38138 |
118 | Baptist Regional Cancer Center | Knoxville | Tennessee | United States | 37920 |
119 | University of Tennessee Cancer Institute | Memphis | Tennessee | United States | 38104 |
120 | Sarah Cannon Cancer Center | Nashville | Tennessee | United States | 37203 |
121 | Meharry Medical College | Nashville | Tennessee | United States | 37208 |
122 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37212 |
123 | Vanderbilt University School of Medicine | Nashville | Tennessee | United States | 37232-6307 |
124 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
125 | Center for Oncology Research & Treatment | Dallas | Texas | United States | 75230 |
126 | Clinical Hematology & Oncology | Dallas | Texas | United States | 75235 |
127 | Oncology Consultants | Houston | Texas | United States | 77024 |
128 | H. Alejandro Preti, M.D., PA | Houston | Texas | United States | 77030 |
129 | M.D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
130 | South Texas Oncology & Hematology | San Antonio | Texas | United States | 78207 |
131 | Scott & White Hospital | Temple | Texas | United States | 76508 |
132 | Northern Utah Cancer Associates | Ogden | Utah | United States | 84403 |
133 | Southwestern Vermont Health Care | Bennington | Vermont | United States | 05201 |
134 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
135 | Cancer Treatment Centers of America in Hampton Roads | Portsmouth | Virginia | United States | 23704 |
136 | Western Washington Clinic | Everett | Washington | United States | 98201 |
137 | Cascade Cancer Center | Kirkland | Washington | United States | 98034 |
138 | Rainier Oncology | Puyallup | Washington | United States | 98372 |
139 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
140 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
141 | West Virginia University Health Sciences Center | Morgantown | West Virginia | United States | 26506 |
142 | Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
143 | Kettle Morain Oncology | West Bend | Wisconsin | United States | 53095 |
144 | Novartis Investigative Site | Frankston | Australia | VIC | |
145 | Novartis Investigative Site | Woodville South | Australia | SA | |
146 | Novartis Investigative Site | St. Veit an der Glan | Austria | 9300 | |
147 | Novartis Investigative Site | Antwerpen | Belgium | 2020 | |
148 | Novartis Investigative Site | Brasschaat | Belgium | 2930 | |
149 | Novartis Investigative Site | Bruxelles | Belgium | 1200 | |
150 | Novartis Investigative Site | Leuven | Belgium | ||
151 | Novartis Investigative Site | Liège | Belgium | 4000 | |
152 | Novartis Investigative Site | Wilrijk | Belgium | 2610 | |
153 | Novartis Investigative Site | Porto Alegre RS | Brazil | CEP 90 610-000 | |
154 | Novartis Investigative Site | Salvador - Ba | Brazil | 41825-010 | |
155 | Novartis Investigative Site | Salvador, Bahia | Brazil | CEP 40170-070 | |
156 | Novartis Investigative Site | Sao Paulo | Brazil | 01236-000 | |
157 | Novartis Investigative Site | Sao Paulo | Brazil | 01308-050 | |
158 | Novartis Investigative Site | Sao Paulo | Brazil | 01406-100 | |
159 | Novartis Investigative Site | Calgary | Alberta | Canada | T2N4N2 |
160 | Novartis Investigative Site | Penticton | British Columbia | Canada | V2A3G6 |
161 | Novartis Investigative Site | Winnepeg | Manitoba | Canada | R2H 2A6 |
162 | Novartis Investigative Site | Sydney | Nova Scotia | Canada | B1P 1P3 |
163 | Novartis Investigative Site | Barrie | Ontario | Canada | L4M6M2 |
164 | Novartis Investigative Site | Brampton | Ontario | Canada | L6W 2Z8 |
165 | Novartis Investigative Site | Hamilton | Ontario | Canada | L8V 5C2 |
166 | Novartis Investigative Site | Ottawa | Ontario | Canada | K1H 1C4 |
167 | Novartis Investigative Site | Sainte-Foy | Ontario | Canada | G1V 4G5 |
168 | Novartis Investigative Site | St. Catharines | Ontario | Canada | L2R5K3 |
169 | Novartis Investigative Site | Sudbury | Ontario | Canada | P3E 5J1 |
170 | Novartis Investigative Site | Thunder Bay | Ontario | Canada | P7A 7T1 |
171 | Toronto | Ontario | Canada | M4C 3E7 | |
172 | Novartis Investigative Site | Toronto | Ontario | Canada | M4N3M5 |
173 | Novartis Investigative Site | Toronto | Ontario | Canada | M5G1X5 |
174 | Novartis Investigative Site | Toronto | Ontario | Canada | |
175 | Novartis Investigative Site | Windsor | Ontario | Canada | N8W 2X3 |
176 | Novartis Investigative Site | Greenfield Park | Quebec | Canada | J4V2H1 |
177 | Novartis Investigative Site | Montreal | Quebec | Canada | H2L 4M1 |
178 | Novartis Investigative Site | Montreal | Quebec | Canada | H2W 1S6 |
179 | Novartis Investigative Site | Saskatoon | Saskatchewan | Canada | S7N4H4 |
180 | Novartis Investigative Site | Avignon | France | 84000 | |
181 | Novartis Investigative Site | Boulogne Cedex | France | 92104 | |
182 | Novartis Investigative Site | Lille cedex | France | 59020 | |
183 | Novartis Investigative Site | Marseille cedex 05 | France | 13385 | |
184 | Novartis Investigative Site | Montpellier cedex 5 | France | 34298 | |
185 | Novartis Investigative Site | Nice cedex 2 | France | 6189 | |
186 | Novartis Investigative Site | Rennes cedex | France | 35042 | |
187 | Novartis Investigative Site | Saint Herblain | France | 44805 | |
188 | Novartis Investigative Site | Strasbourg | France | 67000 | |
189 | Novartis Investigative Site | Toulouse cedex | France | 31052 | |
190 | Novartis Investigative Site | Augsburg | Germany | 86150 | |
191 | Novartis Investigative Site | Berlin | Germany | 13585 | |
192 | Novartis Investigative Site | Berlin | Germany | 14195 | |
193 | Novartis Investigative Site | Bielefeld | Germany | 33604 | |
194 | Novartis Investigative Site | Braunschweig | Germany | 38100 | |
195 | Novartis Investigative Site | Dessau | Germany | 6822 | |
196 | Novartis Investigative Site | Dresden | Germany | 1307 | |
197 | Novartis Investigative Site | Essen | Germany | 45122 | |
198 | Novartis Investigative Site | Essen | Germany | 45136 | |
199 | Novartis Investigative Site | Frankfurt | Germany | 60488 | |
200 | Novartis Investigative Site | Hamburg | Germany | 22087 | |
201 | Novartis Investigative Site | Hannover | Germany | 30625 | |
202 | Novartis Investigative Site | Köln | Germany | 50677 | |
203 | Novartis Investigative Site | Magdeburg | Germany | 39002 | |
204 | Novartis Investigative Site | München | Germany | 81675 | |
205 | Novartis Investigative Site | Neumünster | Germany | 24534 | |
206 | Novartis Investigative Site | Trier | Germany | 54290 | |
207 | Novartis Investigative Site | Ulm | Germany | 89081 | |
208 | Novartis Investigative Site | Wiesbaden | Germany | 65199 | |
209 | Novartis Investigative Site | ChaiWan | Hong Kong | ||
210 | Novartis Investigative Site | Ancona | Italy | 60020 | |
211 | Novartis Investigative Site | Bergamo | Italy | 24128 | |
212 | Novartis Investigative Site | Brescia | Italy | 25124 | |
213 | Novartis Investigative Site | Cremona | Italy | 26100 | |
214 | Novartis Investigative Site | Genova | Italy | 16132 | |
215 | Novartis Investigative Site | Livorno | Italy | 57100 | |
216 | Novartis Investigative Site | Milano | Italy | 20100 | |
217 | Novartis Investigative Site | Milano | Italy | 20141 | |
218 | Novartis Investigative Site | Reggio Emilia | Italy | 42100 | |
219 | Novartis Investigative Site | Roma | Italy | 135 | |
220 | Novartis Investigative Site | Roma | Italy | 149 | |
221 | Novartis Investigative Site | Rozzano | Italy | 20089 | |
222 | Novartis Investigative Site | Auckland | New Zealand | ||
223 | Novartis Investigative Site | Christchurch | New Zealand | ||
224 | Novartis Investigative Site | Wellington | New Zealand | ||
225 | Novartis Investigative Site | Coimbra | Portugal | 3000-076 | |
226 | Novartis Investigative Site | Lisboa | Portugal | 1649-035 | |
227 | Novartis Investigative Site | Bratislava | Slovakia | 81250 | |
228 | Novartis Investigative Site | Cordoba | Spain | 14004 | |
229 | Novartis Investigative Site | Elche | Spain | 3202 | |
230 | Novartis Investigative Site | Madrid | Spain | 28007 | |
231 | Novartis Investigative Site | Madrid | Spain | 28033 | |
232 | Novartis Investigative Site | Madrid | Spain | 28040 | |
233 | Novartis Investigative Site | Madrid | Spain | 8907 | |
234 | Novartis Investigative Site | Malaga | Spain | 29010 | |
235 | Novartis Investigative Site | Zaragoza | Spain | 5009 | |
236 | Novartis Investigative Site | Goteborg | Sweden | SE-416 85 | |
237 | Novartis Investigative Site | Stockholm | Sweden | SE-118 83 | |
238 | Novartis Investigative Site | Bern | Switzerland | 3010 | |
239 | Novartis Investigative Site | Thun | Switzerland | 3600 | |
240 | Novartis Investigative Site | Changhua | Taiwan | ||
241 | Novartis Investigative Site | Kaohsiung | Taiwan | ||
242 | Novartis Investigative Site | Keelung | Taiwan | ||
243 | Novartis Investigative Site | Taichung | Taiwan | ||
244 | Novartis Investigative Site | Tainan | Taiwan | ||
245 | Novartis Investigative Site | Taipei | Taiwan | ||
246 | Novartis Investigative Site | Tao-Yuan | Taiwan | ||
247 | Novartis Investigative Site | Belfast | United Kingdom | BT9 7AB | |
248 | Novartis Investigative Site | Birmingham | United Kingdom | B15 2TH | |
249 | Novartis Investigative Site | Cardiff | United Kingdom | CF147TB | |
250 | Novartis Investigative Site | London | United Kingdom | W1T 3AA | |
251 | Novartis Investigative Site | Manchester | United Kingdom | M20 4BX |
Sponsors and Collaborators
- Novartis Pharmaceuticals
- Bayer
Investigators
- Study Chair: Novartis/Schering AG, Germany, Novartis / Schering AG Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPTK787 0133/304946
- NCT00068679