SPERA: Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)

Sponsor

Agennix (Industry)

Overall Status

Terminated

CT.gov ID

NCT00450970

Collaborator

(none)

344

Enrollment

121

Locations

Arms

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Oral Satraplatin	Phase 3

Detailed Description

UPDATE On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial.

The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Study Design

Study Type:

Interventional

Actual Enrollment :

344 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Prednisone and Satraplatin (INN / USAN), also known as JM-216, or OC-6-43-bis(acetato-O)ammine dichloro (cyclohexanamine)-platinum (IV), is a member of a novel class of platinum (IV) compounds that are absorbed by the oral route. The lipophilic properties of these compounds, and hence their absorption, are largely determined by the nature of the axial acetate ligands.	Drug: Oral Satraplatin The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.
Experimental: 2 Prednisone (17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione) is commercially formulated as the acetate salt (prednisone 21-acetate). It is a biologically inert glucocorticoid, which is converted to active prednisolone in the liver.	Drug: Oral Satraplatin The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.

Arm

Intervention/Treatment

Experimental: 1

Prednisone and Satraplatin (INN / USAN), also known as JM-216, or OC-6-43-bis(acetato-O)ammine dichloro (cyclohexanamine)-platinum (IV), is a member of a novel class of platinum (IV) compounds that are absorbed by the oral route. The lipophilic properties of these compounds, and hence their absorption, are largely determined by the nature of the axial acetate ligands.

Drug: Oral Satraplatin

The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.

Experimental: 2

Prednisone (17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione) is commercially formulated as the acetate salt (prednisone 21-acetate). It is a biologically inert glucocorticoid, which is converted to active prednisolone in the liver.

Drug: Oral Satraplatin

Outcome Measures

Primary Outcome Measures

The SPERA trial is designed to provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited prior cytotoxic chemotherapy regimens for metastatic disease. [Patient evaluation by MD at baseline to determine eligibility.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Metastatic(Stage D2)prostate cancer
Progression after unlimited prior cytotoxic chemotherapy regimens
ECOG Performance status equal/less than 2
Surgical or medical castration
Adequate bone marrow, liver, and renal function
Informed consent
Patients treated with bisphosphonates prior to entry are eligible and should continue bisphosphonates therapy while on this trial

Exclusion Criteria:

Serious concurrent uncontrolled medical disorder
Malignant disease requiring on-going therapy
Prior significant RT/radionuclide therapy
Major GI surgery or GI disease affecting absorption
Disease where corticosteroids are contraindicated
Brain metastases
Poorly-controlled or uncontrolled insulin-dependent diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carraway Cancer Clinic	Birmingham	Alabama	United States	35234
2	Birmingham Hematology and Oncology	Birmingham	Alabama	United States	35235
3	Urology Centers of Alabama	Homewood	Alabama	United States	35209
4	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
5	Genesis Cancer Center	Hot Springs	Arkansas	United States	71913
6	Clopton Clinic	Jonesboro	Arkansas	United States	72401
7	Pacific Cancer Medical Center, Inc	Anaheim	California	United States	92801
8	East Valley Hematology Oncology Medical Group	Burbank	California	United States	91505
9	Pacific Shores Medical Group	Long Beach	California	United States	90813
10	North Valley Hematology/Oncology Medical Group	Mission Hills	California	United States	91345
11	Michael Harris MD	Mission Viejo	California	United States	92691
12	Newport Cancer Care Medical Assoc., Inc.	Newport Beach	California	United States	92663
13	Medical Oncology Care Associates	Orange	California	United States	92868
14	Desert Cancer Center	Rancho Mirage	California	United States	92270
15	Sharp Clinical Oncology Research	San Diego	California	United States	92123
16	Pacific Hematology Oncology Associates	San Francisco	California	United States	94115
17	Santa Barbara Hematology Oncology Medical Group	Santa Barbara	California	United States	93105
18	Santa Barbara Hemotology	Santa Barbara	California	United States	93105
19	Stockton Hematology Oncology Medical Group	Stockton	California	United States	95204
20	Sierra Nevada Oncology	Truckee	California	United States	96161
21	Rocky Mountain Cancer Center	Colorado Springs	Colorado	United States	80909
22	Oncology Associates of Bridgeport	Bridgeport	Connecticut	United States	06611
23	Medical Specialists of Fairfield, LLC	Fairfield	Connecticut	United States	06284
24	Davis, Posteraro, and Wasser, MDs, LLP	Manchester	Connecticut	United States	06040
25	Whittigham Cancer Center at Norwalk Hospital	Norwalk	Connecticut	United States	06856
26	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut	United States	06360
27	Hematology Oncology	Stamford	Connecticut	United States	06902
28	Connecticut Oncology & Hematology, LLP	Torrington	Connecticut	United States	06790
29	Center for Hematology-Oncology	Boca Raton	Florida	United States	33486
30	Florida Cancer Specalists	Bradenton	Florida	United States	34209
31	Florida Cancer Care Specialists-Fort Myers Summerlin Office	Fort Myers	Florida	United States	33908
32	Gainesville Hematology Oncology Associates	Gainesville	Florida	United States	32605
33	ICON	Jacksonville	Florida	United States	32256
34	Lakeland Regional Medical Center	Lakeland	Florida	United States	33805
35	MIMA Century Research Assoc.	Melbourne	Florida	United States	32901
36	Marc I. Saltzman	Miami	Florida	United States	33138
37	Ocala Oncology Center	Ocala	Florida	United States	34474
38	Mid-Florida Hematology & Oncology Centers	Orange City	Florida	United States	32763
39	Sacred Heart Hospital Cancer Research	Pensacola	Florida	United States	32504
40	Florida Cancer Specialists	Port Charlotte	Florida	United States	33980
41	Notheast Georgia Cancer Care, LLC	Athens	Georgia	United States	30607
42	Medical Oncology Assoc. of Augusta, PC	Augusta	Georgia	United States	30901
43	GA Urology	Decatur	Georgia	United States	30033
44	Suburban Hematology-Oncology Assoc., PC	Lawrenceville	Georgia	United States	30045
45	University of Chicago	Chicago	Illinois	United States	60637
46	Medical & Surgical Spealists, LLC	Galesburg	Illinois	United States	61401
47	Urology Associates, S.C.	Mattoon	Illinois	United States	61938
48	Mid-Illinois Hematology and Oncology Assoc., LTD	Normal	Illinois	United States	61761
49	Oncology Hematology Associates of Central IL, PC	Peoria	Illinois	United States	61615
50	Fort Wayne Medical Oncology Hematology, Inc.	Fort Wayne	Indiana	United States	46815
51	Mahendra M. Shah, MD, FACP	Hammond	Indiana	United States	46320
52	McFarland Clinic PC	Ames	Iowa	United States	50010
53	Iowa Blood and Cancer Care, PLC	Cedar Rapids	Iowa	United States	52402
54	Heartland Oncology & Hematology, LLP	Council Bluffs	Iowa	United States	51503
55	Cedar Valley Medical Specialists	Waterloo	Iowa	United States	50702
56	Drs.Caroll, Sheth and Raghavan	Louisville	Kentucky	United States	40215
57	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
58	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20817
59	The Center for Clinical Research	Hagerstown	Maryland	United States	21740
60	Associates in Oncology/Hematology	Rockville	Maryland	United States	20850
61	Lahey Clinic	Burlington	Massachusetts	United States	01805
62	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan	United States	49546
63	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan	United States	49048
64	Jackson Oncology Associates	Jackson	Mississippi	United States	39202
65	NW MS Hem/Onc (Tupelo)	Tupelo	Mississippi	United States	38801
66	Columbia Comprehensive Cancer Care Center	Columbia	Missouri	United States	65201
67	Ellis Fischel Cancer Center	Columbia	Missouri	United States	65203
68	St. Johns Mercy Medical Center	St. Louis	Missouri	United States	63141
69	The Center for Cancer Care & Research	St. Louis	Missouri	United States	63141
70	The Billings Clinic	Billings	Montana	United States	59101
71	Saint Francis Memoiral Hospital	Grand Island	Nebraska	United States	68803
72	Nebraska Hematology-Oncology,PC	Lincoln	Nebraska	United States	68506
73	Cancer Care at St. Claire's	Denville	New Jersey	United States	07834
74	Hematology Oncology Associates of Northern New Jersey	Morristown	New Jersey	United States	07960
75	Northern Valley Medical	Westwood	New Jersey	United States	07675
76	Hematology Oncology Assoc. of W. Suffolk, PC	Bay Shore	New York	United States	11706
77	The Mary Imogene Bassett Hospital	Cooperstown	New York	United States	13326
78	North Shore Hematology Oncology Assoc.	E. Setauket	New York	United States	11733
79	Richmond University Medical Center	Staten Island	New York	United States	10310
80	Gaston Hematology and Oncology	Gastonia	North Carolina	United States	28054
81	Cancer Center of North Carolina	Raleigh	North Carolina	United States	27614
82	MeritCare Clinical Research	Fargo	North Dakota	United States	58122
83	Trinity Cancer Care Center	Minot	North Dakota	United States	58701
84	Tricounty Hem/Onc Associates	Canton	Ohio	United States	44718
85	The Christ Hospital	Cincinnati	Ohio	United States	45219
86	Mid-Ohio Oncology/Hematology	Columbus	Ohio	United States	43219
87	Hematology-Oncology Consultants, Inc	Columbus	Ohio	United States	43235
88	Ohio Cancer Specialists	Mansfield	Ohio	United States	44907
89	Cancer Care Associates	Oklahoma City	Oklahoma	United States	73112
90	Cancer Specialists of Oklahoma	Oklahoma City	Oklahoma	United States	73112
91	Cancer Care Associates	Tulsa	Oklahoma	United States	73146
92	Ephrata Cancer Center	Ephrata	Pennsylvania	United States	17522
93	Lancaster Cancer Center, Ltd.	Lancaster	Pennsylvania	United States	17601
94	Greater Philadelphia Cancer Center	Philadelphia	Pennsylvania	United States	19114
95	Carolina Health Care	Florence	South Carolina	United States	29501
96	Mid-South Cancer Center, PC	Germantown	Tennessee	United States	38138
97	Mid-South Cancer Center	Germantown	Tennessee	United States	38138
98	The Jones Clinic	Germantown	Tennessee	United States	38138
99	McLeod Cancer and Blood Center	Johnson City	Tennessee	United States	37604
100	Kingsport Hematology Oncology	Kingsport	Tennessee	United States	37660
101	Boston Baskin Cancer Group D/B/A/ UTCI	Memphis	Tennessee	United States	38104
102	Harrington Cancer Center	Amarillo	Texas	United States	79106
103	Texas Oncology Cancer Center, PA	Austin	Texas	United States	78731
104	Lone Star Oncology Consultants	Austin	Texas	United States	78759
105	Coastal Bend Cancer Center	Corpus Christi	Texas	United States	78463
106	Mitchell Medical Clinic	Daingerfield	Texas	United States	75638
107	Center for Oncology Research and Treatment	Dallas	Texas	United States	75230
108	Texas Oncology	Dallas	Texas	United States	75231
109	Clinical Oncology & Hematology, LLP	Dallas	Texas	United States	75235
110	Dallas Oncology Consultants, PA	Dallas	Texas	United States	75237
111	Texas Cancer Center	Denton	Texas	United States	76210
112	Cancer Care Centers of South Texas	Fredericksburg	Texas	United States	78624
113	Allison Cancer Center	Midland	Texas	United States	79701
114	Cancer Care Centers of South Texas	New Braunfels	Texas	United States	78130
115	Northern Utah Associates	Ogden	Utah	United States	84403
116	Peninsula Cancer Institute	Newport News	Virginia	United States	23601
117	Virginia Oncology Associates	Newport News	Virginia	United States	23606
118	Sacred Heart Medical Center - Providence Cancer Care Center	Spokane	Washington	United States	99204
119	Northwest Cancer Specialists, PC	Vancouver	Washington	United States	98684
120	Green Bay Oncology, Ltd.	Green Bay	Wisconsin	United States	54301
121	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226