Trial Outcomes & Findings for Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (NCT NCT01338012)
NCT ID: NCT01338012
Last Updated: 2017-06-05
Results Overview
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Study terminated
|
4
|
Baseline Characteristics
Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Sipuleucel-T
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
74.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG 0=Fully Active; No restrictions
|
6 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG 1= Restricted Strenuous Activity
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015Population: 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.
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Outcome measures
| Measure |
Sipuleucel-T
n=8 Participants
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.
|
|---|---|
|
Number of Study Participants Enrolled and Treated Prior to Study Termination
|
8 Participants
|
Adverse Events
Sipuleucel-T
Serious events: 2 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Sipuleucel-T
n=8 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Nervous system disorders
Cerebrovascular accident
|
12.5%
1/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Device alarm issue
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Number of events 3 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Gastrointestinal disorders
Peptic ulcer
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
Other adverse events
| Measure |
Sipuleucel-T
n=8 participants at risk
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.
|
|---|---|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Gastrointestinal disorders
Paraesthesia oral
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Chills
|
62.5%
5/8 • Number of events 6 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 9 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Asthenia
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 3 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Infections and infestations
Sinusitis
|
25.0%
2/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Injury, poisoning and procedural complications
Citrate toxicity
|
12.5%
1/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • Number of events 3 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
25.0%
2/8 • Number of events 4 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 2 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 3 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Nervous system disorders
Paraesthesia
|
25.0%
2/8 • Number of events 3 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER