TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

Sponsor
Amgen (Industry)
Overall Status
Terminated
CT.gov ID
NCT01493505
Collaborator
(none)
1,015
310
2
59
3.3
0.1

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

Study Type:
Interventional
Actual Enrollment :
1015 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Dec 1, 2016

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

  1. Progression free survival [3 years]

Secondary Outcome Measures

  1. Overall survival (OS) [5 years]

  2. Incidence of adverse events and significant laboratory abnormalities [4 years]

  3. 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

  4. Incidence of anti-AMG 386 antibody formation [4 years]

    pre-dose weeks 1, 10, 19

  5. Patient reported ovarian cancer-specific symptoms and health related quality of life [4 years]

  6. Patient reported status as measured by the EuroQOL (EQ-5D) [4 years]

  7. AMG 386 exposure-response relationships for PFS and OS [4 years]

  8. Correlation of serum biomarkers with measures of response [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

  • 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

  • Subjects with FIGO Stage IIIC or IV disease must either:

  • Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or

  • 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

  • ECOG performance status of 0 or 1

  • Adequate bone marrow, renal and hepatic function

Exclusion Criteria:
  • Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer

  • Previous abdominal and/or pelvic external beam radiotherapy

  • History of central nervous metastasis

  • History of arterial or venous thromboembolism within 12 months prior to randomization

  • Clinically significant cardiovascular disease within 12 months prior to randomization

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT01493505
Other Study ID Numbers:
  • 20101129
  • TRINOVA-3 20101129/ENGOT-ov2
First Posted:
Dec 16, 2011
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017

Study Results

No Results Posted as of Feb 23, 2017