TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo Placebo Paclitaxel Carboplatin |
Drug: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Drug: AMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Drug: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
|
Active Comparator: AMG 386 AMG 386 Paclitaxel Carboplatin |
Drug: AMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Drug: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Drug: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
|
Outcome Measures
Primary Outcome Measures
- Progression free survival [3 years]
Secondary Outcome Measures
- Overall survival (OS) [5 years]
- Incidence of adverse events and significant laboratory abnormalities [4 years]
- Pharmacokinetics of AMG 386 (Cmax and Cmin) [1 year]
pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
- Incidence of anti-AMG 386 antibody formation [4 years]
pre-dose weeks 1, 10, 19
- Patient reported ovarian cancer-specific symptoms and health related quality of life [4 years]
- Patient reported status as measured by the EuroQOL (EQ-5D) [4 years]
- AMG 386 exposure-response relationships for PFS and OS [4 years]
- Correlation of serum biomarkers with measures of response [4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
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Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
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Subjects with FIGO Stage IIIC or IV disease must either:
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Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
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Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
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ECOG performance status of 0 or 1
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Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
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Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
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Previous abdominal and/or pelvic external beam radiotherapy
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History of central nervous metastasis
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History of arterial or venous thromboembolism within 12 months prior to randomization
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Clinically significant cardiovascular disease within 12 months prior to randomization
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Research Site | Birmingham | Alabama | United States | 35233 |
2 | Research Site | Mobile | Alabama | United States | 36604 |
3 | Research Site | Anchorage | Alaska | United States | 99508 |
4 | Research Site | Gilbert | Arizona | United States | 85234 |
5 | Research Site | Peoria | Arizona | United States | 85381 |
6 | Research Site | Phoenix | Arizona | United States | 85013 |
7 | Research Site | Phoenix | Arizona | United States | 85016 |
8 | Research Site | Tucson | Arizona | United States | 85710 |
9 | Research Site | Tucson | Arizona | United States | 85724-5024 |
10 | Research Site | Berkeley | California | United States | 94704 |
11 | Research Site | Burbank | California | United States | 91505 |
12 | Research Site | Concord | California | United States | 94520 |
13 | Research Site | Corona | California | United States | 92879 |
14 | Research Site | La Jolla | California | United States | 92093-0957 |
15 | Research Site | Long Beach | California | United States | 90806 |
16 | Research Site | Los Angeles | California | United States | 90027 |
17 | Research Site | Orange | California | United States | 92868 |
18 | Research Site | Oxnard | California | United States | 93030 |
19 | Research Site | Rancho Mirage | California | United States | 92270 |
20 | Research Site | Sacramento | California | United States | 95816 |
21 | Research Site | Sacramento | California | United States | 95817 |
22 | Research Site | San Diego | California | United States | 92123 |
23 | Research Site | Aurora | Colorado | United States | 80045 |
24 | Research Site | Englewood | Colorado | United States | 80113 |
25 | Research Site | Bridgeport | Connecticut | United States | 06606 |
26 | Research Site | Farmington | Connecticut | United States | 06030 |
27 | Research Site | Hartford | Connecticut | United States | 06106 |
28 | Research Site | New Britain | Connecticut | United States | 06050 |
29 | Research Site | Stamford | Connecticut | United States | 06902 |
30 | Research Site | Clearwater | Florida | United States | 33756 |
31 | Research Site | Hollywood | Florida | United States | 33021 |
32 | Research Site | Miami | Florida | United States | 33146 |
33 | Research Site | Orlando | Florida | United States | 32804 |
34 | Research Site | Orlando | Florida | United States | 32806 |
35 | Research Site | St Petersburg | Florida | United States | 33701 |
36 | Research Site | Tampa | Florida | United States | 33612 |
37 | Research Site | Augusta | Georgia | United States | 30912 |
38 | Research Site | Gainesville | Georgia | United States | 30501 |
39 | Research Site | Macon | Georgia | United States | 31201 |
40 | Research Site | Savannah | Georgia | United States | 31404 |
41 | Research Site | Honolulu | Hawaii | United States | 96826 |
42 | Research Site | Chicago | Illinois | United States | 60611 |
43 | Research Site | Chicago | Illinois | United States | 60612 |
44 | Research Site | Chicago | Illinois | United States | 60637 |
45 | Research Site | Decatur | Illinois | United States | 62526 |
46 | Research Site | Evanston | Illinois | United States | 60201 |
47 | Research Site | Hinsdale | Illinois | United States | 60521 |
48 | Research Site | Joliet | Illinois | United States | 60435 |
49 | Research Site | Maywood | Illinois | United States | 60153 |
50 | Research Site | Oak Lawn | Illinois | United States | 60453 |
51 | Research Site | Park Ridge | Illinois | United States | 60068 |
52 | Research Site | Urbana | Illinois | United States | 61801 |
53 | Research Site | Indianapolis | Indiana | United States | 46202 |
54 | Research Site | Indianapolis | Indiana | United States | 46237 |
55 | Research Site | Indianapolis | Indiana | United States | 46260 |
56 | Research Site | Munster | Indiana | United States | 46321 |
57 | Research Site | South Bend | Indiana | United States | 46628 |
58 | Research Site | Ames | Iowa | United States | 50010 |
59 | Research Site | Iowa City | Iowa | United States | 52242 |
60 | Research Site | Kansas City | Kansas | United States | 66160 |
61 | Research Site | Edgewood | Kentucky | United States | 41017 |
62 | Research Site | Lexington | Kentucky | United States | 40536 |
63 | Research Site | Covington | Louisiana | United States | 70433 |
64 | Research Site | Lafayette | Louisiana | United States | 70503 |
65 | Research Site | Scarborough | Maine | United States | 04074 |
66 | Research Site | Baltimore | Maryland | United States | 21204 |
67 | Research Site | Baltimore | Maryland | United States | 21215 |
68 | Research Site | Baltimore | Maryland | United States | 21237 |
69 | Research Site | Boston | Massachusetts | United States | 02114 |
70 | Research Site | Burlington | Massachusetts | United States | 01805 |
71 | Research Site | Danvers | Massachusetts | United States | 01923 |
72 | Research Site | Worcester | Massachusetts | United States | 01605 |
73 | Research Site | Detroit | Michigan | United States | 48201 |
74 | Research Site | Detroit | Michigan | United States | 48202 |
75 | Research Site | Kalamazoo | Michigan | United States | 49007 |
76 | Research Site | Minneapolis | Minnesota | United States | 55416 |
77 | Research Site | Rochester | Minnesota | United States | 55905 |
78 | Research Site | St. Louis Park | Minnesota | United States | 55426 |
79 | Research Site | Jackson | Mississippi | United States | 39216 |
80 | Research Site | Kansas City | Missouri | United States | 64111 |
81 | Research Site | St Louis | Missouri | United States | 63110 |
82 | Research Site | Billings | Montana | United States | 59101 |
83 | Research Site | Lincoln | Nebraska | United States | 68506 |
84 | Research Site | Las Vegas | Nevada | United States | 89169 |
85 | Research Site | Reno | Nevada | United States | 89502 |
86 | Research Site | Lebanon | New Hampshire | United States | 03756 |
87 | Research Site | Hackensack | New Jersey | United States | 07601 |
88 | Research Site | Neptune | New Jersey | United States | 07753 |
89 | Research Site | Voorhees | New Jersey | United States | 08043 |
90 | Research Site | Albuquerque | New Mexico | United States | 87102 |
91 | Research Site | Albuquerque | New Mexico | United States | 87131 |
92 | Research Site | Albany | New York | United States | 12208 |
93 | Research Site | Brightwaters | New York | United States | 11718 |
94 | Research Site | Bronx | New York | United States | 10461 |
95 | Research Site | Buffalo | New York | United States | 14263 |
96 | Research Site | Jamaica | New York | United States | 11432 |
97 | Research Site | Lake Success | New York | United States | 11042 |
98 | Research Site | New York | New York | United States | 10029 |
99 | Research Site | New York | New York | United States | 10032 |
100 | Research Site | New York | New York | United States | 10065 |
101 | Research Site | Syracuse | New York | United States | 13210 |
102 | Research Site | Asheville | North Carolina | United States | 28806 |
103 | Research Site | Burlington | North Carolina | United States | 27215 |
104 | Research Site | Chapel Hill | North Carolina | United States | 27599-7570 |
105 | Research Site | Charlotte | North Carolina | United States | 28204 |
106 | Research Site | Concord | North Carolina | United States | 28025 |
107 | Research Site | Durham | North Carolina | United States | 27710 |
108 | Research Site | Wilmington | North Carolina | United States | 28402 |
109 | Research Site | Winston Salem | North Carolina | United States | 27103 |
110 | Research Site | Winston Salem | North Carolina | United States | 27157 |
111 | Research Site | Fargo | North Dakota | United States | 58122 |
112 | Research Site | Akron | Ohio | United States | 44304 |
113 | Research Site | Canton | Ohio | United States | 44710 |
114 | Research Site | Cincinnati | Ohio | United States | 45220 |
115 | Research Site | Cincinnati | Ohio | United States | 45267-0457 |
116 | Research Site | Cleveland | Ohio | United States | 44106 |
117 | Research Site | Cleveland | Ohio | United States | 44109 |
118 | Research Site | Cleveland | Ohio | United States | 44195 |
119 | Research Site | Columbus | Ohio | United States | 43210 |
120 | Research Site | Columbus | Ohio | United States | 43214 |
121 | Research Site | Kettering | Ohio | United States | 45429 |
122 | Research Site | Mayfield Heights | Ohio | United States | 44124 |
123 | Research Site | Toledo | Ohio | United States | 43614 |
124 | Research Site | Oklahoma City | Oklahoma | United States | 73104 |
125 | Research Site | Tulsa | Oklahoma | United States | 74136 |
126 | Research Site | Bend | Oregon | United States | 97701 |
127 | Research Site | Abington | Pennsylvania | United States | 19001 |
128 | Research Site | Bethlehem | Pennsylvania | United States | 18015 |
129 | Research Site | Philadelphia | Pennsylvania | United States | 19104 |
130 | Research Site | Philadelphia | Pennsylvania | United States | 19107 |
131 | Research Site | Pittsburgh | Pennsylvania | United States | 15213 |
132 | Research Site | Pittsburgh | Pennsylvania | United States | 15224 |
133 | Research Site | Radnor | Pennsylvania | United States | 19087 |
134 | Research Site | West Reading | Pennsylvania | United States | 19611 |
135 | Research Site | Providence | Rhode Island | United States | 02905 |
136 | Research Site | Charleston | South Carolina | United States | 29425 |
137 | Research Site | Columbia | South Carolina | United States | 29210 |
138 | Research Site | Greenville | South Carolina | United States | 29601 |
139 | Research Site | Greenville | South Carolina | United States | 29605 |
140 | Research Site | Sioux Falls | South Dakota | United States | 57105 |
141 | Research Site | Chattanooga | Tennessee | United States | 37403 |
142 | Research Site | Austin | Texas | United States | 78701 |
143 | Research Site | Austin | Texas | United States | 78731 |
144 | Research Site | Bedford | Texas | United States | 76022 |
145 | Research Site | Dallas | Texas | United States | 75231 |
146 | Research Site | Dallas | Texas | United States | 75246 |
147 | Research Site | Dallas | Texas | United States | 75390-9032 |
148 | Research Site | Galveston | Texas | United States | 77555 |
149 | Research Site | Houston | Texas | United States | 77030 |
150 | Research Site | San Antonio | Texas | United States | 78217 |
151 | Research Site | The Woodlands | Texas | United States | 77380 |
152 | Research Site | Ogden | Utah | United States | 84403 |
153 | Research Site | Burlington | Vermont | United States | 05401 |
154 | Research Site | Annandale | Virginia | United States | 22003 |
155 | Research Site | Charlottesville | Virginia | United States | 22908 |
156 | Research Site | Norfolk | Virginia | United States | 23502 |
157 | Research Site | Roanoke | Virginia | United States | 24016 |
158 | Research Site | Winchester | Virginia | United States | 22601 |
159 | Research Site | Woodbridge | Virginia | United States | 22191 |
160 | Research Site | Seattle | Washington | United States | 98104 |
161 | Research Site | Tacoma | Washington | United States | 98405 |
162 | Research Site | Wenatchee | Washington | United States | 98801 |
163 | Research Site | Green Bay | Wisconsin | United States | 54301 |
164 | Research Site | Green Bay | Wisconsin | United States | 54311 |
165 | Research Site | Marshfield | Wisconsin | United States | 54449 |
166 | Research Site | Milwaukee | Wisconsin | United States | 53215 |
167 | Research Site | Milwaukee | Wisconsin | United States | 53226 |
168 | Research Site | Milwaukee | Wisconsin | United States | 53233 |
169 | Research Site | Oshkosh | Wisconsin | United States | 54904 |
170 | Research Site | Sheboygan | Wisconsin | United States | 53081 |
171 | Research Site | Waukesha | Wisconsin | United States | 53188 |
172 | Research Site | Wausau | Wisconsin | United States | 54401 |
173 | Research Site | West Allis | Wisconsin | United States | 53227 |
174 | Research Site | Graz | Austria | 8020 | |
175 | Research Site | Graz | Austria | 8036 | |
176 | Research Site | Innsbruck | Austria | 6020 | |
177 | Research Site | Linz | Austria | 4010 | |
178 | Research Site | Linz | Austria | 4020 | |
179 | Research Site | Salzburg | Austria | 5020 | |
180 | Research Site | Wien | Austria | 1130 | |
181 | Research Site | Bonheiden | Belgium | 2820 | |
182 | Research Site | Brasschaat | Belgium | 2930 | |
183 | Research Site | Bruxelles | Belgium | 1000 | |
184 | Research Site | Charleroi | Belgium | 6000 | |
185 | Research Site | Duffel | Belgium | 2570 | |
186 | Research Site | Edegem | Belgium | 2650 | |
187 | Research Site | Gent | Belgium | 9000 | |
188 | Research Site | Hasselt | Belgium | 3500 | |
189 | Research Site | Kortrijk | Belgium | 8500 | |
190 | Research Site | Leuven | Belgium | 3000 | |
191 | Research Site | Libramont | Belgium | 6800 | |
192 | Research Site | Liège | Belgium | 4000 | |
193 | Research Site | Namur | Belgium | 5000 | |
194 | Research Site | Oostende | Belgium | 8400 | |
195 | Research Site | Sint-Niklaas | Belgium | 9100 | |
196 | Research Site | Turnhout | Belgium | 2300 | |
197 | Research Site | Wilrijk | Belgium | 2610 | |
198 | Research Site | Yvoir | Belgium | 5530 | |
199 | Research Site | Calgary | Alberta | Canada | T2N 4N2 |
200 | Research Site | Edmonton | Alberta | Canada | T6G 1Z2 |
201 | Research Site | Halifax | Nova Scotia | Canada | B3H 1V7 |
202 | Research Site | Kingston | Ontario | Canada | K7L 5P9 |
203 | Research Site | London | Ontario | Canada | N6A 4L6 |
204 | Research Site | Sault Ste. Marie | Ontario | Canada | P6B 0A8 |
205 | Research Site | Toronto | Ontario | Canada | M4N 3M5 |
206 | Research Site | Toronto | Ontario | Canada | M5G 2M9 |
207 | Research Site | Montreal | Quebec | Canada | H2L 4M1 |
208 | Research Site | Quebec | Canada | G1R 2J6 | |
209 | Research Site | Herlev | Denmark | 2730 | |
210 | Research Site | København Ø | Denmark | 2100 | |
211 | Research Site | Roskilde | Denmark | 4000 | |
212 | Research Site | Berlin | Germany | 13353 | |
213 | Research Site | Dresden | Germany | 01307 | |
214 | Research Site | Düsseldorf | Germany | 40217 | |
215 | Research Site | Düsseldorf | Germany | 40225 | |
216 | Research Site | Erlangen | Germany | 91054 | |
217 | Research Site | Essen | Germany | 45136 | |
218 | Research Site | Essen | Germany | 45147 | |
219 | Research Site | Frankfurt am Main | Germany | 60590 | |
220 | Research Site | Frankfurt am Main | Germany | 65929 | |
221 | Research Site | Freiburg | Germany | 79106 | |
222 | Research Site | Hamburg | Germany | 20246 | |
223 | Research Site | Hannover | Germany | 30177 | |
224 | Research Site | Hannover | Germany | 30625 | |
225 | Research Site | Kiel | Germany | 24105 | |
226 | Research Site | Konstanz | Germany | 78464 | |
227 | Research Site | Leipzig | Germany | 04103 | |
228 | Research Site | Ludwigsburg | Germany | 71640 | |
229 | Research Site | München | Germany | 80337 | |
230 | Research Site | München | Germany | 81377 | |
231 | Research Site | München | Germany | 81675 | |
232 | Research Site | Oldenburg | Germany | 26121 | |
233 | Research Site | Ravensburg | Germany | 88212 | |
234 | Research Site | Rostock | Germany | 18059 | |
235 | Research Site | Stuttgart | Germany | 70374 | |
236 | Research Site | Tübingen | Germany | 72076 | |
237 | Research Site | Ulm | Germany | 89075 | |
238 | Research Site | Athens | Greece | 11522 | |
239 | Research Site | Athens | Greece | 11527 | |
240 | Research Site | Athens | Greece | 11528 | |
241 | Research Site | Athens | Greece | 14564 | |
242 | Research Site | Larissa | Greece | 41110 | |
243 | Research Site | Patra | Greece | 26500 | |
244 | Research Site | Thessaloniki | Greece | 56429 | |
245 | Research Site | Hong Kong | Hong Kong | ||
246 | Research Site | Kowloon | Hong Kong | ||
247 | Research Site | New Territories | Hong Kong | ||
248 | Research Site | Avellino | Italy | 83100 | |
249 | Research Site | Aviano PN | Italy | 33081 | |
250 | Research Site | Bari | Italy | 70124 | |
251 | Research Site | Bologna | Italy | 40138 | |
252 | Research Site | Brescia | Italy | 25123 | |
253 | Research Site | Genova | Italy | 16132 | |
254 | Research Site | Milano | Italy | 20133 | |
255 | Research Site | Milano | Italy | 20141 | |
256 | Research Site | Napoli | Italy | 80131 | |
257 | Research Site | Novara | Italy | 28100 | |
258 | Research Site | Palermo | Italy | 90126 | |
259 | Research Site | Pisa | Italy | 56126 | |
260 | Research Site | Roma | Italy | 00144 | |
261 | Research Site | Roma | Italy | 00168 | |
262 | Research Site | Torino | Italy | 10126 | |
263 | Research Site | Nagoya-city | Aichi | Japan | 464-8681 |
264 | Research Site | Kashiwa | Chiba | Japan | 277-8567 |
265 | Research Site | Fukuoka-shi | Fukuoka | Japan | 811-1395 |
266 | Research Site | Kurume-city | Fukuoka | Japan | 830-0011 |
267 | Research Site | Kure-city | Hiroshima | Japan | 737-0023 |
268 | Research Site | Sapporo-city | Hokkaido | Japan | 003-0804 |
269 | Research Site | Morioka-city | Iwate | Japan | 020-8505 |
270 | Research Site | Kitaadachi-gun | Saitama | Japan | 362-0806 |
271 | Research Site | Suntou-gun | Shizuoka | Japan | 411-8777 |
272 | Research Site | Yonago-city | Tottori | Japan | 683-8504 |
273 | Research Site | Tokyo | Japan | 105-8471 | |
274 | Research Site | Tokyo | Japan | 160-8582 | |
275 | Research Site | Goyang-si, Gyeonggi-do | Korea, Republic of | 410-769 | |
276 | Research Site | Seoul | Korea, Republic of | 110-744 | |
277 | Research Site | Seoul | Korea, Republic of | 135-710 | |
278 | Research Site | Seoul | Korea, Republic of | 138-736 | |
279 | Research Site | Deventer | Netherlands | 7416 SE | |
280 | Research Site | Leiden | Netherlands | 2333 ZA | |
281 | Research Site | Nijmegen | Netherlands | 6525 GA | |
282 | Research Site | Rotterdam | Netherlands | 3015 CE | |
283 | Research Site | Chelyabinsk | Russian Federation | 454087 | |
284 | Research Site | Ivanovo | Russian Federation | 153013 | |
285 | Research Site | Krasnodar | Russian Federation | 350040 | |
286 | Research Site | Moscow | Russian Federation | 115478 | |
287 | Research Site | Obninsk | Russian Federation | 249036 | |
288 | Research Site | Pyatigorsk | Russian Federation | 357502 | |
289 | Research Site | Saint Petersburg | Russian Federation | 197022 | |
290 | Research Site | Ufa | Russian Federation | 450054 | |
291 | Research Site | Voronezh | Russian Federation | 394000 | |
292 | Research Site | Zaragoza | Aragón | Spain | 50009 |
293 | Research Site | Oviedo | Asturias | Spain | 33006 |
294 | Research Site | Palma de Mallorca | Baleares | Spain | 07198 |
295 | Research Site | Badalona | Cataluña | Spain | 08916 |
296 | Research Site | Barcelona | Cataluña | Spain | 08035 |
297 | Research Site | Girona | Cataluña | Spain | 17007 |
298 | Research Site | Lleida | Cataluña | Spain | 25198 |
299 | Research Site | Valencia | Comunidad Valenciana | Spain | 46009 |
300 | Research Site | Valencia | Comunidad Valenciana | Spain | 46014 |
301 | Research Site | Valencia | Comunidad Valenciana | Spain | 46026 |
302 | Research Site | El Palmar | Murcia | Spain | 30120 |
303 | Research Site | Madrid | Spain | 28009 | |
304 | Research Site | Madrid | Spain | 28033 | |
305 | Research Site | Madrid | Spain | 28034 | |
306 | Research Site | Madrid | Spain | 28040 | |
307 | Research Site | Madrid | Spain | 28041 | |
308 | Research Site | Madrid | Spain | 28046 | |
309 | Research Site | Madrid | Spain | 28050 | |
310 | Research Site | Madrid | Spain | 28922 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 20101129
- TRINOVA-3 20101129/ENGOT-ov2