Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT01217697

Collaborator

(none)

305

Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

Condition or Disease	Intervention/Treatment	Phase
Prostate Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male	Drug: Abiraterone Acetate Drug: Prednisone\Prednisolone

Detailed Description

This is a study to collect information on adverse events (side effects) that occur during treatment with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate. CRPC is progressive form of prostate cancer where the cancer cells become resistant to hormonal therapies that are designed to block the release or uptake of testosterone and the cancer cells metastasize (ie, spread to other parts of the body). Abiraterone acetate (referred to as abiraterone) is a drug currently under development for use in treating men with CRPC. Patients will be treated with abiraterone and prednisone daily until progression of clinical disease (ie, includes signs of clinical disease progression and/or clinical disease progression confirmed by radiographic and prostate-specific antigen [PSA] test results). Other reasons for discontinuation of treatment may include adverse events reported, initiation of other anticancer therapies, or the patient's inability to comply with dosing instructions. Patients will be followed for 30 days after the discontinuation of treatment with abiraterone acetate. Patients will take four 250-mg tablets of abiraterone orally at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. Patients will also take 5 mg of oral prednisone, twice daily. Each treatment cycle consists of 28 days and patients will take abiraterone continually on a daily basis until disease progression is observed at which time abiraterone will be discontinued and the dose of prednisone reduced if clinically indicated.

Study Design

Study Type:

Expanded Access

Official Title:

An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed prostate cancer
Prostate cancer progression after previous chemotherapy as assessed by the investigator
Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
Serum testosterone of less than 50ng/dL (less than 2.0 nM)
Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)

Exclusion Criteria:

Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
Known brain metastasis (ie, spread of cancer to the brain)

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Mobile	Alabama	United States
3	Chandler	Arizona	United States
4	Scottsdale	Arizona	United States
5	Tucson	Arizona	United States
6	Anaheim	California	United States
7	Bellflower	California	United States
8	Berkeley	California	United States
9	Beverly Hills	California	United States
10	Duarte	California	United States
11	Encinitas	California	United States
12	Glendale	California	United States
13	Greenbrae	California	United States
14	La Jolla	California	United States
15	Laguna Hills	California	United States
16	Long Beach	California	United States
17	Los Angeles	California	United States
18	Marina Del Rey	California	United States
19	Rancho Mirage	California	United States
20	San Diego	California	United States
21	San Francisco	California	United States
22	Santa Rosa	California	United States
23	Stanford	California	United States
24	Aurora	Colorado	United States
25	Colorado Springs	Colorado	United States
26	Denver	Colorado	United States
27	Fort Collins	Colorado	United States
28	Littleton	Colorado	United States
29	Hartford	Connecticut	United States
30	Manchester	Connecticut	United States
31	New Britain	Connecticut	United States
32	Norwalk	Connecticut	United States
33	Norwich	Connecticut	United States
34	Southington	Connecticut	United States
35	Stamford	Connecticut	United States
36	Torrington	Connecticut	United States
37	Trumball	Connecticut	United States
38	Washington	District of Columbia	United States
39	Boca Raton	Florida	United States
40	Fort Lauderdale	Florida	United States
41	Fort Myers	Florida	United States
42	Gainesville	Florida	United States
43	Miami	Florida	United States
44	Ocala	Florida	United States
45	Orlando	Florida	United States
46	Palm Beach Gardens	Florida	United States
47	Port Saint Lucie	Florida	United States
48	South Miami	Florida	United States
49	Atlanta	Georgia	United States
50	Savannah	Georgia	United States
51	Honolulu	Hawaii	United States
52	Post Falls	Idaho	United States
53	Chicago	Illinois	United States
54	Decatur	Illinois	United States
55	Harvey	Illinois	United States
56	Niles	Illinois	United States
57	Peoria	Illinois	United States
58	Urbana	Illinois	United States
59	Fort Wayne	Indiana	United States
60	Lafayette	Indiana	United States
61	Merrillville	Indiana	United States
62	Muncie	Indiana	United States
63	Bettendorf	Iowa	United States
64	Westwood	Kansas	United States
65	Lexington	Kentucky	United States
66	Louisville	Kentucky	United States
67	Marrero	Louisiana	United States
68	New Orleans	Louisiana	United States
69	Bangor	Maine	United States
70	Scarborough	Maine	United States
71	Easton	Maryland	United States
72	Rockville	Maryland	United States
73	Boston	Massachusetts	United States
74	Worcester	Massachusetts	United States
75	Dearborn	Michigan	United States
76	Detroit	Michigan	United States
77	Grand Rapids	Michigan	United States
78	Lansing	Michigan	United States
79	Rochester	Minnesota	United States
80	Saint Louis Park	Minnesota	United States
81	St. Joseph	Missouri	United States
82	Billings	Montana	United States
83	Omaha	Nebraska	United States
84	Las Vegas	Nevada	United States
85	Hooksett	New Hampshire	United States
86	Portsmouth	New Hampshire	United States
87	Cherry Hill	New Jersey	United States
88	Hackensack	New Jersey	United States
89	Livingston	New Jersey	United States
90	Morristown	New Jersey	United States
91	New Brunswick	New Jersey	United States
92	Paramus	New Jersey	United States
93	Los Alamos	New Mexico	United States
94	Albany	New York	United States
95	Binghamton	New York	United States
96	Bronx	New York	United States
97	Brooklyn	New York	United States
98	Buffalo	New York	United States
99	Cooperstown	New York	United States
100	Dunkirk	New York	United States
101	East Setauket	New York	United States
102	East Syracuse	New York	United States
103	Fresh Meadows	New York	United States
104	Glens Falls	New York	United States
105	Mt. Kisco	New York	United States
106	New Hyde Park	New York	United States
107	New York	New York	United States
108	Rochester	New York	United States
109	Stony Brook	New York	United States
110	Syracuse	New York	United States
111	Chapel Hill	North Carolina	United States
112	Charlotte	North Carolina	United States
113	Durham	North Carolina	United States
114	Greenville	North Carolina	United States
115	Hendersonville	North Carolina	United States
116	High Point	North Carolina	United States
117	Huntersville	North Carolina	United States
118	Pinehurst	North Carolina	United States
119	Raleigh	North Carolina	United States
120	Cincinnati	Ohio	United States
121	Cleveland	Ohio	United States
122	Columbus	Ohio	United States
123	Dayton	Ohio	United States
124	Elyria	Ohio	United States
125	Massillon	Ohio	United States
126	Middletown	Ohio	United States
127	Sandusky	Ohio	United States
128	Bethany	Oklahoma	United States
129	Oklahoma City	Oklahoma	United States
130	Portland	Oregon	United States
131	Allentown	Pennsylvania	United States
132	Philadelphia	Pennsylvania	United States
133	West Reading	Pennsylvania	United States
134	Providence	Rhode Island	United States
135	Charleston	South Carolina	United States
136	Columbia	South Carolina	United States
137	Greenville	South Carolina	United States
138	Myrtle Beach	South Carolina	United States
139	Bristol	Tennessee	United States
140	Chattanooga	Tennessee	United States
141	Memphis	Tennessee	United States
142	Nashville	Tennessee	United States
143	Austin	Texas	United States
144	Corpus Christi	Texas	United States
145	Dallas	Texas	United States
146	Galveston	Texas	United States
147	Houston	Texas	United States
148	San Antonio	Texas	United States
149	Temple	Texas	United States
150	The Woodlands	Texas	United States
151	Salt Lake City	Utah	United States
152	Burlington	Vermont	United States
153	Hampton	Virginia	United States
154	Newport News	Virginia	United States
155	Norfolk	Virginia	United States
156	Seattle	Washington	United States
157	Milwaukee	Wisconsin	United States
158	Adelaide		Australia
159	Bedford Park		Australia
160	Box Hill		Australia
161	Camperdown		Australia
162	Footscray		Australia
163	Garran		Australia
164	Geelong		Australia
165	Heidelberg		Australia
166	Herston		Australia
167	Hobart		Australia
168	Kogarah		Australia
169	Kurralta Park		Australia
170	Liverpool		Australia
171	Nedlands		Australia
172	Port Macquarie		Australia
173	Randwick		Australia
174	South Brisbane		Australia
175	Southport Qld		Australia
176	Subiaco		Australia
177	Sydney		Australia
178	Tamworth		Australia
179	Wahroonga		Australia
180	Westmead		Australia
181	Wodonga		Australia
182	Woolloongabba		Australia
183	Belo Horizonte		Brazil
184	Curitiba		Brazil
185	Porto Alegre		Brazil
186	Recife		Brazil
187	Rio De Janeiro		Brazil
188	Salvador		Brazil
189	Sao Paulo		Brazil
190	São Paulo		Brazil
191	Kelowna	British Columbia	Canada
192	Vancouver	British Columbia	Canada
193	Victoria	British Columbia	Canada
194	Halifax	Nova Scotia	Canada
195	Hamilton	Ontario	Canada
196	Kingston	Ontario	Canada
197	Ottawa	Ontario	Canada
198	Toronto	Ontario	Canada
199	Montreal	Quebec	Canada
200	Regina	Saskatchewan	Canada
201	Calgary		Canada
202	London		Canada
203	N/a N/a		Canada
204	Quebec		Canada
205	Bogota		Colombia
206	Floridablanca		Colombia
207	Medellin		Colombia
208	Monteria		Colombia
209	Pereira		Colombia
210	Valledupar		Colombia
211	Split		Croatia
212	Zagreb		Croatia
213	Brno		Czech Republic
214	Hradec Kralove		Czech Republic
215	Olomouc		Czech Republic
216	Praha 2		Czech Republic
217	Usti Nad Labem		Czech Republic
218	Aarhus		Denmark
219	Copenhagen Ø		Denmark
220	Köpenhamn Ö		Denmark
221	Athens Attica		Greece
222	Athens		Greece
223	Crete		Greece
224	Larisa		Greece
225	Patra		Greece
226	Thessalonikis		Greece
227	Hk		Hong Kong
228	Hong Kong		Hong Kong
229	New Territories		Hong Kong
230	Sha Tin		Hong Kong
231	Budapest N/A		Hungary
232	Budapest		Hungary
233	Zalaegerszeg-P Zva N/A		Hungary
234	Jakarta		Indonesia
235	Hwasun Gun		Korea, Republic of
236	Seongnam-Si, Gyeonggi-Do		Korea, Republic of
237	Seoul		Korea, Republic of
238	Jalan Cheras N/A		Malaysia
239	Kota Kinabalu		Malaysia
240	Kuala Lumpur N/A		Malaysia
241	Kuala Lumpur		Malaysia
242	Subang Jaya		Malaysia
243	Acapulco, Guerrero		Mexico
244	Aguascalientes		Mexico
245	Chihuahua		Mexico
246	Ciudad De Mexico		Mexico
247	Cuernavaca		Mexico
248	Distrito Federal		Mexico
249	Durango		Mexico
250	Guadalajara		Mexico
251	Leon		Mexico
252	Mexico City		Mexico
253	Mexico, D.F.		Mexico
254	Monterrey		Mexico
255	Oaxaca		Mexico
256	Veracruz		Mexico
257	Zamora		Mexico
258	Christchurch		New Zealand
259	Grafton		New Zealand
260	Hamilton		New Zealand
261	Palmerston North		New Zealand
262	Wellington		New Zealand
263	Gdansk		Poland
264	Lodz		Poland
265	Opole		Poland
266	Otwock		Poland
267	Wroclaw		Poland
268	Ponce		Puerto Rico
269	San Juan		Puerto Rico
270	Brasov		Romania
271	Bucuresti		Romania
272	Cluj-Napoca		Romania
273	Iasi		Romania
274	Barnaul		Russian Federation
275	Ekaterinburg		Russian Federation
276	Kazan		Russian Federation
277	Moscow		Russian Federation
278	Nizhny Novgorod		Russian Federation
279	Obninsk		Russian Federation
280	Omsk		Russian Federation
281	Pyatigorsk		Russian Federation
282	Rostov-On-Don		Russian Federation
283	Saint-Petersburg		Russian Federation
284	St Petersburg		Russian Federation
285	St-Petersburg		Russian Federation
286	Stavropol		Russian Federation
287	Ufa		Russian Federation
288	Singapore		Singapore
289	Badajoz		Spain
290	Barakaldo Vizcaya		Spain
291	Barcelona		Spain
292	Cordoba		Spain
293	Hospitalet. Barcelona		Spain
294	La Coruña		Spain
295	Madrid		Spain
296	Palma De Mallorca		Spain
297	Salamanca		Spain
298	Santa Cruz De Tenerife		Spain
299	Sevilla		Spain
300	Toledo		Spain
301	Valencia		Spain
302	Kaohsiung County		Taiwan
303	Kaohsiung		Taiwan
304	Taoyuan		Taiwan
305	Bangkok		Thailand

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.