Trial · NCT00606008
A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma
NCT00606008, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma. Trials, record NCT00606008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00606008
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma
- NCT number
- NCT00606008
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Anaplastic Astrocytoma, Glioblastoma
- Interventions
- Sunitinib Malate
- First posted
- 2008-02-01
- Last updated
- 2012-11-19
- Results first posted
- 2012-10-31
- Limitations and caveats
No definitive conclusions can be made regarding outcome differences between bevacizumab vs. bevacizumab-naive study patients, due to not enough patients who received bevacizumab prior to study enrollment (2 AA, 3 GB).
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse | 6 Months | Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions. |
| Secondary | Best Overall Response | 12 Months | To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment). |
| Secondary | Number of Participants With Related Grade 3 and Greater Adverse Events | 12 Months | To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse | 6 Months | All participants | Participants | NUMBER |
| SECONDARY | Best Overall Response | 12 Months | All participants | Participants | NUMBER |
| SECONDARY | Number of Participants With Related Grade 3 and Greater Adverse Events | 12 Months | All participants | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse | Sutent Treatment | 4 | Participants | ||
| Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse | AA Cohort Patients | 2 | Participants | ||
| Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse | GB Cohort Patients | 2 | Participants | ||
| Best Overall Response | Sutent Treatment | 13 | Participants | ||
| Best Overall Response | AA Cohort Patients | 8 | Participants | ||
| Best Overall Response | GB Cohort Patients | 5 | Participants | ||
| Number of Participants With Related Grade 3 and Greater Adverse Events | Sutent Treatment | 11 | Participants | ||
| Number of Participants With Related Grade 3 and Greater Adverse Events | AA Cohort Patients | 6 | Participants | ||
| Number of Participants With Related Grade 3 and Greater Adverse Events | GB Cohort Patients | 5 | 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 | Sutent Treatment | 30 | |
| Overall Study | COMPLETED | Sutent Treatment | 25 | |
| Overall Study | NOT COMPLETED | Sutent Treatment | 5 |
Source ClinicalTrials.gov
Adverse events312
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 | Fatigue (asthenia, lethargy, malaise) | General disorders | Sutent Treatment | 21 | 30 | 27 |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | AA Cohort Patients | 11 | 14 | 12 |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | GB Cohort Patients | 10 | 16 | 15 |
| other | Dermatology/Skin - other | Skin and subcutaneous tissue disorders | Sutent Treatment | 7 | 30 | 9 |
| other | Dermatology/Skin - other | Skin and subcutaneous tissue disorders | AA Cohort Patients | 4 | 14 | 5 |
| other | Dermatology/Skin - other | Skin and subcutaneous tissue disorders | GB Cohort Patients | 3 | 16 | 4 |
| other | Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | Sutent Treatment | 3 | 30 | 3 |
| other | Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | AA Cohort Patients | 2 | 14 | 2 |
| other | Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | GB Cohort Patients | 1 | 16 | 1 |
| other | Constipation | Gastrointestinal disorders | Sutent Treatment | 7 | 30 | 8 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sutent Treatment | ||
| Total, all-cause mortality | AA Cohort Patients | ||
| Total, all-cause mortality | GB Cohort Patients | ||
| Total, other adverse events | Sutent Treatment | 28 | 30 |
| Total, other adverse events | AA Cohort Patients | 14 | 14 |
| Total, other adverse events | GB Cohort Patients | 14 | 16 |
| Total, serious adverse events | Sutent Treatment | 11 | 30 |
| Total, serious adverse events | AA Cohort Patients | 6 | 14 |
| Total, serious adverse events | GB Cohort Patients | 5 | 16 |
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/NCT00606008
GET https://conductscience.org/api/trials/v1/NCT00606008/events?page=2