Trial Outcomes & Findings for Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer (NCT NCT00901342)
NCT ID: NCT00901342
Last Updated: 2017-05-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Results posted on
2017-05-23
Participant Flow
Participant milestones
| Measure |
Sipuleucel-T
Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
|
|---|---|
|
Overall Study
STARTED
|
104
|
|
Overall Study
Received at Least 1 Infusion
|
98
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Sipuleucel-T
Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
4
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
Baseline Characteristics
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Sipuleucel-T
n=104 Participants
Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=5 Participants
|
|
Age, Continuous
|
69.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
104 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG 0=Fully Active; No restrictions.
|
66 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG 1= Restricted Strenuous Activity
|
35 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG 2=Ambulatory, capable of self-care; no work
|
3 Participants
n=5 Participants
|
|
Gleason Score
Gleason Score ≤ 6
|
16 Participants
n=5 Participants
|
|
Gleason Score
Gleason Score = 7
|
35 Participants
n=5 Participants
|
|
Gleason Score
Gleason Score ≥ 8
|
51 Participants
n=5 Participants
|
|
Gleason Score
Gleason Score Missing
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (first infusion) and up to 3 infusions at 2-week intervalsPopulation: Participants who Received At least 1 Infusion
Outcome measures
| Measure |
Sipuleucel-T
n=98 Participants
All subjects who received ≥ one sipuleucel-T infusion
|
|---|---|
|
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
|
98 participants
|
Adverse Events
Sipuleucel-T
Serious events: 13 serious events
Other events: 91 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Sipuleucel-T
n=98 participants at risk
Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
|
|---|---|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Nervous system disorders
Presyncope
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/98 • Number of events 2 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Fatigue
|
2.0%
2/98 • Number of events 2 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
2/98 • Number of events 2 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Oral pain
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Pain
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/98 • Number of events 1 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
2/98 • Number of events 2 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
Other adverse events
| Measure |
Sipuleucel-T
n=98 participants at risk
Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
6/98 • Number of events 14 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
8/98 • Number of events 8 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Nervous system disorders
Dizziness
|
9.2%
9/98 • Number of events 10 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Nervous system disorders
Headache
|
8.2%
8/98 • Number of events 11 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Psychiatric disorders
Anxiety
|
7.1%
7/98 • Number of events 7 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
6/98 • Number of events 7 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Asthenia
|
6.1%
6/98 • Number of events 6 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Injury, poisoning and procedural complications
Citrate toxicity
|
6.1%
6/98 • Number of events 8 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Vascular disorders
Hypertension
|
6.1%
6/98 • Number of events 7 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Oedema peripheral
|
5.1%
5/98 • Number of events 5 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
6/98 • Number of events 6 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
5/98 • Number of events 6 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
5/98 • Number of events 6 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
5/98 • Number of events 5 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
5/98 • Number of events 7 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Fatigue
|
28.6%
28/98 • Number of events 35 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Nausea
|
18.4%
18/98 • Number of events 21 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Chills
|
17.3%
17/98 • Number of events 25 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.2%
11/98 • Number of events 11 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
11/98 • Number of events 11 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
11.2%
11/98 • Number of events 18 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
Gastrointestinal disorders
Constipation
|
10.2%
10/98 • Number of events 10 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
|
General disorders
Pyrexia
|
10.2%
10/98 • Number of events 11 • Subjects were assessed for safety not less than 30 days post-final infusion with sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse events, and cerebrovascular events (CVE)s were collected via Long Term Follow-up Telephone Assessment every 6 months until subject death or study conclusion.
Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.
|
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 centers. 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