Trial · NCT00715078
To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
NCT00715078, Phase 2, Completed, Dendreon; results first posted 2014-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen. Trials, record NCT00715078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00715078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
- NCT number
- NCT00715078
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Prostate Cancer
- Interventions
- sipuleucel-T
- First posted
- 2008-07-15
- Last updated
- 2017-05-23
- Results first posted
- 2014-05-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. | Baseline, Months 2, 4 and 6. | An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. | Baseline, Months 2, 4 and 6. | Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject. | Ratio ofCD54 molecules on BDS65:FP cells | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. | Cohort A | 29.53 | Standard Error 1.285 | Ratio ofCD54 molecules on BDS65:FP cells | |
| Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. | Cohort B | 30.94 | Standard Error 1.418 | Ratio ofCD54 molecules on BDS65:FP cells | |
| Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. | Cohort C | 26.67 | Standard Error 1.194 | Ratio ofCD54 molecules on BDS65:FP cells |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 41 | |
| Overall Study | STARTED | Cohort B | 40 | |
| Overall Study | STARTED | Cohort C | 41 | |
| Overall Study | Received ≥ 1 Study Infusion | Cohort A | 40 | |
| Overall Study | Received ≥ 1 Study Infusion | Cohort B | 40 | |
| Overall Study | Received ≥ 1 Study Infusion | Cohort C | 39 | |
| Overall Study | Received ≥ 1 Leukapheresis | Cohort A | 40 | |
| Overall Study | Received ≥ 1 Leukapheresis | Cohort B | 40 | |
| Overall Study | Received ≥ 1 Leukapheresis | Cohort C | 40 | |
| Overall Study | COMPLETED | Cohort A | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events399
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort A | 6 | 40 | 6 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort B | 4 | 40 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort C | 8 | 40 | 8 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Cohort A | 0 | 40 | 0 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Cohort B | 1 | 40 | 1 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Cohort C | 2 | 40 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort A | 4 | 40 | 4 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort B | 2 | 40 | 3 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort C | 3 | 40 | 3 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Cohort A | 2 | 40 | 2 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 29 | 40 |
| Total, all-cause mortality | Cohort B | 36 | 40 |
| Total, all-cause mortality | Cohort C | 36 | 40 |
| Total, other adverse events | Cohort A | 38 | 40 |
| Total, other adverse events | Cohort B | 40 | 40 |
| Total, other adverse events | Cohort C | 40 | 40 |
| Total, serious adverse events | Cohort A | 10 | 40 |
| Total, serious adverse events | Cohort B | 9 | 40 |
| Total, serious adverse events | Cohort C | 11 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00715078
GET https://conductscience.org/api/trials/v1/NCT00715078/events?page=2