Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
No longer available
CT.gov ID
NCT00302016
Collaborator
(none)
272
Study Details
Study Description
Brief Summary
This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
Official Title:
An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
Nov 1, 2008
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Imatinib-resistant or -intolerant Philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase.
-
Chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor.
-
Laboratory values within normal limits.
Exclusion criteria:
-
Impaired cardiac function.
-
Acute or chronic liver or renal disease considered unrelated to tumor.
-
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
-
Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or to inhibit the metabolism of AMN107 (CYP3A4/5 inhibitors).
-
Patients with a history of another malignancy that is currently clinically significant or currently requires active intervention.
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama Cancer Research Institute | Mobile | Alabama | United States | 36693 |
| 2 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
| 3 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 4 | Antelope Valley Cancer Center | Lancaster | California | United States | 93534 |
| 5 | Stanford University | Palo Alto | California | United States | 94304 |
| 6 | University of Colorado | Aurora | Colorado | United States | 80010 |
| 7 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80218 |
| 8 | Georgetown University Medical Center-Lombardi Cancer Center | Washington | District of Columbia | United States | 20007-2113 |
| 9 | Washington Cancer Institute | Washington | District of Columbia | United States | 20010 |
| 10 | Osler Medical Inc./Osler Clinical Research | Melbourne | Florida | United States | 32901 |
| 11 | Advanced Medical Specialties | Miami | Florida | United States | 33176 |
| 12 | Integrated Community | Orange Park | Florida | United States | 32073 |
| 13 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
| 14 | MD Anderson Cancer Center | Orlando | Florida | United States | 32806 |
| 15 | Hematology Oncology Assoc. | Pensacola | Florida | United States | 32501 |
| 16 | Emory University Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 17 | Medical College of Georgia | Augusta | Georgia | United States | 30912 |
| 18 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 19 | Stroger Cook County Hospital | Chicago | Illinois | United States | 60612 |
| 20 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 21 | University of Chicago Hospital | Chicago | Illinois | United States | 60637 |
| 22 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 23 | St. Francis Hospital & Health Centers | Beech Grove | Indiana | United States | 46107 |
| 24 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
| 25 | Cancer Center of Kansas | Wichita | Kansas | United States | 67214 |
| 26 | Louisville Oncology Research | Louisville | Kentucky | United States | 40202 |
| 27 | LSU Health Sciences Center | Shreveport | Louisiana | United States | 71103 |
| 28 | St. Agnes Hospital | Baltimore | Maryland | United States | 21229 |
| 29 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 30 | Wayne State University | Detroit | Michigan | United States | 48201 |
| 31 | St. John Hospital and Medical Center | Grosse Pointe | Michigan | United States | 48236 |
| 32 | Mayo Clinic Hospital | Rochester | Minnesota | United States | 55905 |
| 33 | Southeast Nebraska Cancer Center | Lincoln | Nebraska | United States | 68516 |
| 34 | Nebraska Methodist Cancer Center | Omaha | Nebraska | United States | 68114 |
| 35 | Nevada Cancer Institute | Las Vegas | Nevada | United States | 89135 |
| 36 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 37 | University of New Mexico Health Sciences Center | Albuquerque | New Mexico | United States | 87131 |
| 38 | Cancer Institute of New Mexico | Santa Fe | New Mexico | United States | 87505 |
| 39 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 40 | Winthrop Hematology/Oncology | Mineola | New York | United States | 11501 |
| 41 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10017 |
| 42 | Weill Cornell Medical Center | New York | New York | United States | 10021 |
| 43 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 44 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 45 | Duke University | Durham | North Carolina | United States | 27710 |
| 46 | Wake Forest University | Winston Salem | North Carolina | United States | 27157 |
| 47 | Cancer Care Associates | Oklahoma City | Oklahoma | United States | 734112 |
| 48 | Cancer Care Associates | Tulsa | Oklahoma | United States | 74136 |
| 49 | Oregon Health Sciences University | Portland | Oregon | United States | 97239 |
| 50 | Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | United States | 15224 |
| 51 | Charleston Hematology Oncology | Charleston | South Carolina | United States | 29403 |
| 52 | MUSC Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
| 53 | Three Medical Park | Columbia | South Carolina | United States | 29203 |
| 54 | Cancer Center of the Carolinas | Greenville | South Carolina | United States | 29615 |
| 55 | The Jones Clinic | Germantown | Tennessee | United States | 38138 |
| 56 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 57 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 58 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
| 59 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 60 | Novartis Investigative Site | Saint Leonards | Australia | ||
| 61 | Novartis Investigative Site | Graz | Austria | ||
| 62 | Novartis Investigative Site | Innsbruck | Austria | ||
| 63 | Novartis Investigative Site | Linz | Austria | ||
| 64 | Novartis Investigative Site | Wels | Austria | ||
| 65 | Novartis Investigative Site | Wien | Austria | ||
| 66 | Novartis Investigative Site | Aalst | Belgium | ||
| 67 | Novartis Investigative Site | Antwerpen | Belgium | ||
| 68 | Novartis Investigative Site | Arlon | Belgium | ||
| 69 | Novartis Investigative Site | Brugge | Belgium | ||
| 70 | Novartis Investigative Site | Brussels | Belgium | ||
| 71 | Novartis Investigative Site | Bruxelles | Belgium | ||
| 72 | Novartis Investigative Site | Edegem | Belgium | ||
| 73 | Novartis Investigative Site | Gent | Belgium | ||
| 74 | Novartis Investigative Site | Hasselt | Belgium | ||
| 75 | Novartis Investigative Site | La Louviere | Belgium | ||
| 76 | Novartis Investigative Site | Leuven | Belgium | ||
| 77 | Novartis Investigative Site | Liege | Belgium | ||
| 78 | Novartis Investigative Site | Roeselare | Belgium | ||
| 79 | Novartis Investigative Site | Verviers | Belgium | ||
| 80 | Novartis Investigative Site | Yvoir | Belgium | ||
| 81 | Novartis Investigative Site | Belo Horizonte | Brazil | ||
| 82 | Novartis Investigative Site | Brasilia-DF | Brazil | ||
| 83 | Novartis Investigative Site | Campinas | Brazil | ||
| 84 | Novartis Investigative Site | Curitaba | Brazil | ||
| 85 | Novartis Investigative Site | Curitiba | Brazil | ||
| 86 | Novartis Investigative Site | Porto Alegre-RS | Brazil | ||
| 87 | Novartis Investigative Site | Ribeirao Preto | Brazil | ||
| 88 | Novartis Investigative Site | Rio de Janeiro | Brazil | ||
| 89 | Novartis Investigative Site | Sao Paulo | Brazil | ||
| 90 | Novartis Investigative Site | Edmonton | Canada | ||
| 91 | Novartis Investigative Site | Halifax | Canada | ||
| 92 | Novartis Investigative Site | Hamilton | Canada | ||
| 93 | Novartis Investigative Site | Montreal | Canada | ||
| 94 | Novartis Investigative Site | Ottawa | Canada | ||
| 95 | Novartis Investigative Site | Toronto | Canada | ||
| 96 | Novartis Investigative Site | Vancouver | Canada | ||
| 97 | Novartis Investigative Site | Beijing | China | ||
| 98 | Novartis Investigative Site | Guangzhou | China | ||
| 99 | Novartis Investigative Site | Shanghai | China | ||
| 100 | Novartis Investigative Site | Tianjing | China | ||
| 101 | Novartis Investigative Site | Brno | Czech Republic | ||
| 102 | Novartis Investigative Site | Hradec Kralove | Czech Republic | ||
| 103 | Novartis Investigative Site | Olomouc | Czech Republic | ||
| 104 | Novartis Investigative Site | Plzen-Lochotin | Czech Republic | ||
| 105 | Novartis Investigative Site | Praha 2 | Czech Republic | ||
| 106 | Novartis Investigative Site | Copenhagen | Denmark | ||
| 107 | Novartis Investigative Site | Vejle | Denmark | ||
| 108 | Novartis Investigative Site | Angers | France | ||
| 109 | Novartis Investigative Site | Bordeaux | France | ||
| 110 | Novartis Investigative Site | Caen | France | ||
| 111 | Novartis Investigative Site | Clermont-Ferrand | France | ||
| 112 | Novartis Investigative Site | Creteil | France | ||
| 113 | Novartis Investigative Site | Dijon | France | ||
| 114 | Novartis Investigative Site | Grenoble | France | ||
| 115 | Novartis Investigative Site | Le Chesnay | France | ||
| 116 | Novartis Investigative Site | Lille | France | ||
| 117 | Novartis Investigative Site | Limoges | France | ||
| 118 | Novartis Investigative Site | Lyon | France | ||
| 119 | Novartis Investigative Site | Marseille | France | ||
| 120 | Novartis Investigative Site | Nantes | France | ||
| 121 | Novartis Investigative Site | Nice | France | ||
| 122 | Novartis Investigative Site | Paris | France | ||
| 123 | Novartis Investigative Site | Poitiers | France | ||
| 124 | Novartis Investigative Site | Reims | France | ||
| 125 | Novartis Investigative Site | Rennes | France | ||
| 126 | Novartis Investigative Site | Rouen | France | ||
| 127 | Novartis Investigative Site | Strasbourg | France | ||
| 128 | Novartis Investigative Site | Toulouse | France | ||
| 129 | Novartis Investigative Site | Vandoeuvre les Nancy | France | ||
| 130 | Novartis Investigative Site | Vandoeuvre | France | ||
| 131 | Novartis Investigative Site | Aschaffenburg | Germany | ||
| 132 | Novartis Investigative Site | Augsburg | Germany | ||
| 133 | Novartis Investigative Site | Berlin | Germany | ||
| 134 | Novartis Investigative Site | Braunschweig | Germany | ||
| 135 | Novartis Investigative Site | Bremen | Germany | ||
| 136 | Novartis Investigative Site | Bremerhaven | Germany | ||
| 137 | Novartis Investigative Site | Chemnitz | Germany | ||
| 138 | Novartis Investigative Site | Dresden | Germany | ||
| 139 | Novartis Investigative Site | Essen | Germany | ||
| 140 | Novartis Investigative Site | Frankfurt | Germany | ||
| 141 | Novartis Investigative Site | Freiburg | Germany | ||
| 142 | Novartis Investigative Site | Greifswald | Germany | ||
| 143 | Novartis Investigative Site | Hamburg | Germany | ||
| 144 | Novartis Investigative Site | Hannover | Germany | ||
| 145 | Novartis Investigative Site | Heidelberg | Germany | ||
| 146 | Novartis Investigative Site | Kiel | Germany | ||
| 147 | Novartis Investigative Site | Koln | Germany | ||
| 148 | Novartis Investigative Site | Leipzig | Germany | ||
| 149 | Novartis Investigative Site | Mainz | Germany | ||
| 150 | Novartis Investigative Site | Mannheim | Germany | ||
| 151 | Novartis Investigative Site | Marburg | Germany | ||
| 152 | Novartis Investigative Site | Munchen | Germany | ||
| 153 | Novartis Investigative Site | Oldenburg | Germany | ||
| 154 | Novartis Investigative Site | Osnabruck | Germany | ||
| 155 | Novartis Investigative Site | Regensburg | Germany | ||
| 156 | Novartis Investigative Site | Stuttgart | Germany | ||
| 157 | Novartis Investigative Site | Tubingen | Germany | ||
| 158 | Novartis Investigative Site | Ulm | Germany | ||
| 159 | Novartis Investigative Site | Weiden | Germany | ||
| 160 | Novartis Investigative Site | Wiesbaden | Germany | ||
| 161 | Novartis Investigative Site | Athens | Greece | ||
| 162 | Novartis Investigative Site | Pokfulam | Hong Kong | ||
| 163 | Novartis Investigative Site | Budapest | Hungary | ||
| 164 | Novartis Investigative Site | Dublin | Ireland | ||
| 165 | Novartis Investigative Site | Ancona | Italy | ||
| 166 | Novartis Investigative Site | Bari | Italy | ||
| 167 | Novartis Investigative Site | Bologna | Italy | ||
| 168 | Novartis Investigative Site | Bolzano | Italy | ||
| 169 | Novartis Investigative Site | Brescia | Italy | ||
| 170 | Novartis Investigative Site | Cagliari | Italy | ||
| 171 | Novartis Investigative Site | Campobasso | Italy | ||
| 172 | Novartis Investigative Site | Catania | Italy | ||
| 173 | Novartis Investigative Site | Catanzaro | Italy | ||
| 174 | Novartis Investigative Site | Ferrara | Italy | ||
| 175 | Novartis Investigative Site | Firenze | Italy | ||
| 176 | Novartis Investigative Site | Genova | Italy | ||
| 177 | Novartis Investigative Site | Milano | Italy | ||
| 178 | Novartis Investigative Site | Monza | Italy | ||
| 179 | Novartis Investigative Site | Napoli | Italy | ||
| 180 | Novartis Investigative Site | Novara | Italy | ||
| 181 | Novartis Investigative Site | Nuoro | Italy | ||
| 182 | Novartis Investigative Site | Orbassano | Italy | ||
| 183 | Novartis Investigative Site | Padova | Italy | ||
| 184 | Novartis Investigative Site | Palermo | Italy | ||
| 185 | Novartis Investigative Site | Pavia | Italy | ||
| 186 | Novartis Investigative Site | Perugia | Italy | ||
| 187 | Novartis Investigative Site | Pesaro | Italy | ||
| 188 | Novartis Investigative Site | Pescara | Italy | ||
| 189 | Novartis Investigative Site | Pisa | Italy | ||
| 190 | Novartis Investigative Site | Reggio Calabria | Italy | ||
| 191 | Novartis Investigative Site | Reggio Emilia | Italy | ||
| 192 | Novartis Investigative Site | Rionero in Vulture | Italy | ||
| 193 | Novartis Investigative Site | Roma | Italy | ||
| 194 | Novartis Investigative Site | Ronciglione | Italy | ||
| 195 | Novartis Investigative Site | San Giovanni Rotundo | Italy | ||
| 196 | Novartis Investigative Site | Siena | Italy | ||
| 197 | Novartis Investigative Site | Tarante | Italy | ||
| 198 | Novartis Investigative Site | Torino | Italy | ||
| 199 | Novartis Investigative Site | Udine | Italy | ||
| 200 | Novartis Investigative Site | Via Pansini | Italy | ||
| 201 | Novartis Investigative Site | Daegu | Korea, Republic of | ||
| 202 | Novartis Investigative Site | Deajeon | Korea, Republic of | ||
| 203 | Novartis Investigative Site | Jeollanam-do | Korea, Republic of | ||
| 204 | Novartis Investigative Site | Pusan | Korea, Republic of | ||
| 205 | Novartis Investigative Site | Seoul | Korea, Republic of | ||
| 206 | Novartis Investigative Site | Beirut | Lebanon | ||
| 207 | Novartis Investigative Site | Georgetown, Penang | Malaysia | ||
| 208 | Novartis Investigative Site | Kuala Lumpur | Malaysia | ||
| 209 | Novartis Investigative Site | Pulau Pinang | Malaysia | ||
| 210 | Novartis Investigative Site | Subang Jaya, Selangor | Malaysia | ||
| 211 | Novartis Investigative Site | Mexico D.F. | Mexico | ||
| 212 | Novartis Investigative Site | Amsterdam | Netherlands | ||
| 213 | Novartis Investigative Site | Enschede | Netherlands | ||
| 214 | Novartis Investigative Site | Leiden | Netherlands | ||
| 215 | Novartis Investigative Site | Maastricht | Netherlands | ||
| 216 | Novartis Investigative Site | Rotterdam | Netherlands | ||
| 217 | Novartis Investigative Site | Oslo | Norway | ||
| 218 | Novartis Investigative Site | Gdansk | Poland | ||
| 219 | Novartis Investigative Site | Krakow | Poland | ||
| 220 | Novartis Investigative Site | Poznan | Poland | ||
| 221 | Novartis Investigative Site | Szczecin | Poland | ||
| 222 | Novartis Investigative Site | Warszawa | Poland | ||
| 223 | Novartis Investigative Site | Chelyabinsk | Russian Federation | ||
| 224 | Novartis Investigative Site | Moscow | Russian Federation | ||
| 225 | Novartis Investigative Site | Novosibirsk | Russian Federation | ||
| 226 | Novartis Investigative Site | Saint-Petersburg | Russian Federation | ||
| 227 | Novartis Investigative Site | Samara | Russian Federation | ||
| 228 | Novartis Investigative Site | Ufa | Russian Federation | ||
| 229 | Novartis Investigative Site | Singapore | Singapore | ||
| 230 | Novartis Investigative Site | Bratislava | Slovakia | ||
| 231 | Novartis Investigative Site | Kosice | Slovakia | ||
| 232 | Novartis Investigative Site | Cape Town | South Africa | ||
| 233 | Novartis Investigative Site | Johannesburg | South Africa | ||
| 234 | Novartis Investigative Site | Roodepoort, Gauteng | South Africa | ||
| 235 | Novartis Investigative Site | Baracaldo, Pais Vasco | Spain | ||
| 236 | Novartis Investigative Site | Barcelona, Cataluna | Spain | ||
| 237 | Novartis Investigative Site | Cataluna | Spain | ||
| 238 | Novartis Investigative Site | Granada, Andalucia | Spain | ||
| 239 | Novartis Investigative Site | Las Palmas de Gran Canaria | Spain | ||
| 240 | Novartis Investigative Site | Madrid | Spain | ||
| 241 | Novartis Investigative Site | Malaga | Spain | ||
| 242 | Novartis Investigative Site | Murcia | Spain | ||
| 243 | Novartis Investigative Site | Salamanca, Castilla y Leon | Spain | ||
| 244 | Novartis Investigative Site | San Sabastian, Pais Vasco | Spain | ||
| 245 | Novartis Investigative Site | Santiago de Compostela | Spain | ||
| 246 | Novartis Investigative Site | Valencia | Spain | ||
| 247 | Novartis Investigative Site | Zaragoza | Spain | ||
| 248 | Novartis Investigative Site | Goteborg | Sweden | ||
| 249 | Novartis Investigative Site | Linkoping | Sweden | ||
| 250 | Novartis Investigative Site | Lund | Sweden | ||
| 251 | Novartis Investigative Site | Stockholm | Sweden | ||
| 252 | Novartis Investigative Site | Uppsala | Sweden | ||
| 253 | Novartis Investigative Site | Basel | Switzerland | ||
| 254 | Novartis Investigative Site | Bern | Switzerland | ||
| 255 | Novartis Investigative Site | Lausanne | Switzerland | ||
| 256 | Novartis Investigative Site | Zurich | Switzerland | ||
| 257 | Novartis Investigative Site | Chiayi | Taiwan | ||
| 258 | Novartis Investigative Site | Kaohsiung | Taiwan | ||
| 259 | Novartis Investigative Site | Taichung | Taiwan | ||
| 260 | Novartis Investigative Site | Tainan | Taiwan | ||
| 261 | Novartis Investigative Site | Taipei | Taiwan | ||
| 262 | Novartis Investigative Site | Bangkok | Thailand | ||
| 263 | Novartis Investigative Site | Ankara | Turkey | ||
| 264 | Novartis Investigative Site | Istanbul | Turkey | ||
| 265 | Novartis Investigative Site | Malatya | Turkey | ||
| 266 | Novartis Investigative Site | Samsun | Turkey | ||
| 267 | Novartis Investigative Site | Cambridge | United Kingdom | ||
| 268 | Novartis Investigative Site | Leeds | United Kingdom | ||
| 269 | Novartis Investigative Site | Liverpool | United Kingdom | ||
| 270 | Novartis Investigative Site | London | United Kingdom | ||
| 271 | Novartis Investigative Site | Manchester | United Kingdom | ||
| 272 | Novartis Investigative Site | Nottingham | United Kingdom |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00302016
Other Study ID Numbers:
- CAMN107A2109
- NCT00532649
First Posted:
Mar 13, 2006
Last Update Posted:
Aug 26, 2011
Last Verified:
Aug 1, 2011
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: