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Administrative reasons.
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Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone.
Study Objectives:
Primary: Evaluate the immune response generated by sipuleucel-T.
Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sipuleucel-T | Experimental | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sipuleucel-T | Biological | Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants Enrolled and Treated Prior to Study Termination | Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination. | Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Israel, MD | Valeant Pharmaceuticals North America LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Urology Associates | Laguna Hills | California | 92653 | United States | ||
| Oregon Health & Science University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Men who previously participated in Dendreon's P-11 clinical study, received Sipuleucel-T as part of P-11, and who developed metastatic castrate resistant prostate cancer (mCRPC), Safety population includes all subjects who received at least one infusion in the current study (P10-1).
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| ID | Title | Description |
|---|---|---|
| BG000 | Sipuleucel-T | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Study Participants Enrolled and Treated Prior to Study Termination | Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination. | This study was terminated early due to administrative reasons. Only eight subjects out of the ninety subjects planned were enrolled and treated. Given the small number of patients enrolled, results should be interpreted with caution. | Posted | Count of Participants | Participants | Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 |
|
Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
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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 | Sipuleucel-T | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
This study was terminated early due to administrative reasons. Only 8 subjects were enrolled and treated. Given the small number of patients enrolled, analyses do not provide reliable results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shabnam Vaziri | Dendreon | 206-455-2323 | svaziri@dendreon.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
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|
|
| Portland |
| Oregon |
| 97239 |
| United States |
| Virginia Mason Hospital | Seattle | Washington | 98101 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) performance status | ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead | Count of Participants | Participants |
|
|
|
| 4 |
| 8 |
| 2 |
| 8 |
| 8 |
| 8 |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Device alarm issue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Citrate toxicity | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating center. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |