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This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APC8015F | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APC8015F | Biological | APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of APC8015F by Review of Reported Adverse Events | All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events. | periodically over 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Schellhammer, MD | Devine Tidewater Urology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | United States | |||
| USC Keck School of Medicine |
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| Label | URL |
|---|---|
| (Prostate Cancer Research Institute) | View source |
| (National Prostate Cancer Coalition) | View source |
| (USTOO International) |
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Participants who had objective disease progression on Dendreon's Phase 3 trial D9902B (NCT00065442)and who were determined to have received placebo were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participants were registered between April 2004 and January 2009 across 52 clinical trial sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | APC8015F | APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Los Angeles |
| California |
| United States |
| Sutter Cancer Center | Sacramento | California | United States |
| Kaiser Permanente Medical Group | San Diego | California | United States |
| Sharp HealthCare | San Diego | California | United States |
| UCSF Cancer Center | San Francisco | California | United States |
| Helen F. Graham Cancer Center | Newark | Delaware | United States |
| Lombardi Cancer Center | Washington D.C. | District of Columbia | United States |
| Walter Reid Army Medical Center | Washington D.C. | District of Columbia | United States |
| Miami Cancer Center | Miami | Florida | United States |
| Hematology/Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | United States |
| Georgia Urology, P.A. | Atlanta | Georgia | United States |
| Midwest Prostate & Urology Health Center | Chicago | Illinois | United States |
| Loyola University | Maywood | Illinois | United States |
| Lutheran General Cancer Center | Park Ridge | Illinois | United States |
| Indiana University | Indianapolis | Indiana | United States |
| Myron I Murdock MD LLC | Greenbelt | Maryland | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | United States |
| Lahey Clinic (Department of Urology) | Burlington | Massachusetts | United States |
| University of Minnesota | Minneapolis | Minnesota | United States |
| Mayo Clinic | Rochester | Minnesota | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | United States |
| Associates in Urology, LLC | West Orange | New Jersey | United States |
| Albany Regional Cancer Center | Albany | New York | United States |
| The Urological Institute of Northeastern New York | Albany | New York | United States |
| North Shore Hematology Oncology Associates | East Setauket | New York | United States |
| New York Medical College | Hawthorne | New York | United States |
| Beth Israel Cancer Center | New York | New York | United States |
| Clinical Cancer Center | New York | New York | United States |
| Mount Sinai School of Medicine | New York | New York | United States |
| New York University | New York | New York | United States |
| Staten Island Urological Research | Staten Island | New York | United States |
| McKay Urology | Charlotte | North Carolina | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| University of Cincinnati | Cincinnati | Ohio | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | United States |
| EACRI | Portland | Oregon | United States |
| Kaiser Permanente Medical Group | Portland | Oregon | United States |
| Center for Urologic Care | Bryn Mawr | Pennsylvania | United States |
| Jefferson Medical College | Philadelphia | Pennsylvania | United States |
| Grand Strand Urology | Myrtle Beach | South Carolina | United States |
| Mary Crowley | Dallas | Texas | United States |
| Baylor College of Medicine | Houston | Texas | United States |
| University of Utah | Salt Lake City | Utah | United States |
| Urology of Virginia, PC | Norfolk | Virginia | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | United States |
| Virginia Mason Medical Center | Seattle | Washington | United States |
| Cancer Care Northwest | Spokane | Washington | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | United States |
| University of Wisconsin, Madison | Madison | Wisconsin | United States |
| University of Wisconsin | Madison | Wisconsin | United States |
| St. Luke's Hospital Immunotherapy Program | Milwaukee | Wisconsin | United States |
| Can-Med Medical Research, Inc. | Victoria | British Columbia | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Princess Margaret Hospital | Toronto | Ontario | Canada |
| Sunnybrook & Women's College HSC | Toronto | Ontario | Canada |
| Hospital Notre Dame du CHUM | Montreal | Quebec | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | APC8015F | Subjects receiving APC8015F |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of APC8015F by Review of Reported Adverse Events | All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events. | All participants who received at least one infusion of APC8015F | Posted | Count of Participants | Participants | periodically over 24 months |
|
|
|
4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety.
Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had > 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with <1 occurrence of the same event are counted only once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | APC8015F | Subjects receiving at least one infusion of APC8015F | 32 | 109 | 101 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Puncture site haemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
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| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Ureteric obstruction | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Poor venous access | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Dendreon Corporation | 206-455-2476 | clinical@dendreon.com |