Trial · NCT00831792
TKI258 in Castrate Resistant Prostate Cancer
NCT00831792, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2019-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TKI258 in Castrate Resistant Prostate Cancer. Trials, record NCT00831792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00831792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TKI258 in Castrate Resistant Prostate Cancer
- NCT number
- NCT00831792
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Prostate Cancer
- Interventions
- TK1258
- First posted
- 2009-01-29
- Last updated
- 2019-09-11
- Results first posted
- 2019-09-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Improvement, Disease Progression or Stable Disease | From the time of enrollment until 30 days beyond the date of the last study drug administration | Three consecutive PSA elevations above nadir or baseline are required for progression. Each increment in PSA should be a minimum of 1 ng/ml and at least 2 weeks apart or will not count. The time of PSA progression will be taken as the time of the first of these PSA elevations that represents an increment by at least 25% above the nadir or baseline. Given that increments in PSA do not always represent treatment failure, particularly when novel agents with uncertain effects on PSA levels are being evaluated, clinical and radiological correlation is recommended at the discretion of the treating physician. In patients with PSA progression alone without clinical or radiological evidence of disease progression, continued therapy on study is at the discretion of the treating physician in consultation with the principal investigator. |
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 | The Number of Participants With Improvement, Disease Progression or Stable Disease | From the time of enrollment until 30 days beyond the date of the last study drug administration | Patients completed at least 1 cycle of therapy | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| The Number of Participants With Improvement, Disease Progression or Stable Disease | APatients on Observational Study of TKI258 | Bone scan/soft tissue mets improvements at 8 wks | 6 | Participants | |
| The Number of Participants With Improvement, Disease Progression or Stable Disease | APatients on Observational Study of TKI258 | Disease progression | 4 | Participants | |
| The Number of Participants With Improvement, Disease Progression or Stable Disease | APatients on Observational Study of TKI258 | experienced stable disease at 8 weeks | 13 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eligible Patients | 46 | |
| Overall Study | COMPLETED | Eligible Patients | 40 | |
| Overall Study | NOT COMPLETED | Eligible Patients | 6 |
Source ClinicalTrials.gov
Adverse events154
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 | Alkaline phosphatase | Metabolism and nutrition disorders | All Patients Enrolled and Treated With TKI 258 | 23 | 40 | |
| other | Allergy/Immunology-Other (Specify) | Immune system disorders | All Patients Enrolled and Treated With TKI 258 | 1 | 40 | |
| other | Alopecia | Endocrine disorders | All Patients Enrolled and Treated With TKI 258 | 1 | 40 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | All Patients Enrolled and Treated With TKI 258 | 10 | 40 | |
| other | Amylase | Metabolism and nutrition disorders | All Patients Enrolled and Treated With TKI 258 | 4 | 40 | |
| other | Anemia | Metabolism and nutrition disorders | All Patients Enrolled and Treated With TKI 258 | 8 | 40 | |
| other | Anorexia | Metabolism and nutrition disorders | All Patients Enrolled and Treated With TKI 258 | 22 | 40 | |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | All Patients Enrolled and Treated With TKI 258 | 15 | 40 | |
| other | Ataxia (incoordination) | Nervous system disorders | All Patients Enrolled and Treated With TKI 258 | 1 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | All Patients Enrolled and Treated With TKI 258 | 1 | 40 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients Enrolled and Treated With TKI 258 | 0 | 40 |
| Total, other adverse events | All Patients Enrolled and Treated With TKI 258 | 40 | 40 |
| Total, serious adverse events | All Patients Enrolled and Treated With TKI 258 | 2 | 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/NCT00831792
GET https://conductscience.org/api/trials/v1/NCT00831792/events?page=2