Trial · NCT00330564
Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow
NCT00330564, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2011-06-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow. Trials, record NCT00330564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00330564
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow
- NCT number
- NCT00330564
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Von Hippel-Lindau Syndrome, Renal Cell Carcinoma, Hemangioblastoma
- Interventions
- SU011248
- First posted
- 2006-05-29
- Last updated
- 2024-06-27
- Results first posted
- 2011-06-30
- Limitations and caveats
- Limitations include the conclusion of the study before maximum enrollment and the use of archival tissue that was not related to the participants in the clinical trial.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL) | 12 weeks | Safety evaluation = Number of participants with treatment terminating toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Early stopping rules applied when treatment terminating toxicity occurred in the first 6 week cycle. Recurring grade 3 toxicity requires dose reduction, with no more than 2 dose reductions permitted. If no improvement after 4 weeks, patient is taken off drug and off study, and the event recorded as treatment terminating toxicity. |
| Secondary | Number of VHL Lesion Complete + Partial Responses | Baseline to 12 months (evaluations at 6 and 12 months) | Response of VHL lesions (number) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): 20% increase in LD sum and Stable Disease (SD): Insufficient shrinkage to qualify for PR nor increase to qualify for PD. Degree and timing of response in affected organs evaluated in order to determine organ specific kinetics of therapy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of VHL Lesion Complete + Partial Responses | Baseline to 12 months (evaluations at 6 and 12 months) | Secondary end point of efficacy showed response of renal cell carcinomas, which responded better to sunitinib therapy than other VHL related lesions using RECIST measure. | VHL lesion | NUMBER |
| PRIMARY | Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL) | 12 weeks | Intent to treat once the first dose was taken. | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Number of VHL Lesion Complete + Partial Responses | SU011248 (Sutent, Sunitinib Malate) | CR | 0 | VHL lesion | |
| Number of VHL Lesion Complete + Partial Responses | SU011248 (Sutent, Sunitinib Malate) | PR | 6 | VHL lesion | |
| Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL) | SU011248 (Sutent, Sunitinib Malate) | 15 | 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 | SU011248 (Sutent, Sunitinib Malate) | 15 | |
| Overall Study | COMPLETED | SU011248 (Sutent, Sunitinib Malate) | 15 | |
| Overall Study | NOT COMPLETED | SU011248 (Sutent, Sunitinib Malate) | 0 |
Source ClinicalTrials.gov
Adverse events5
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 | Neutropenia | Blood and lymphatic system disorders | SU011248 (Sutent, Sunitinib Malate) | 4 | 15 | 4 |
| other | fatigue | General disorders | SU011248 (Sutent, Sunitinib Malate) | 5 | 15 | 5 |
| other | hand foot syndrome | Skin and subcutaneous tissue disorders | SU011248 (Sutent, Sunitinib Malate) | 2 | 15 | 2 |
| other | hypertension | Cardiac disorders | SU011248 (Sutent, Sunitinib Malate) | 1 | 15 | 1 |
| other | nausea | Gastrointestinal disorders | SU011248 (Sutent, Sunitinib Malate) | 2 | 15 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SU011248 (Sutent, Sunitinib Malate) | ||
| Total, other adverse events | SU011248 (Sutent, Sunitinib Malate) | 14 | 15 |
| Total, serious adverse events | SU011248 (Sutent, Sunitinib Malate) | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22105611 | RESULT |
Source PubMed
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/NCT00330564
GET https://conductscience.org/api/trials/v1/NCT00330564/registered