Trial · NCT00453895
Sunitinib in Refractory Adrenocortical Carcinoma
NCT00453895, Phase 2, Completed, University of Wuerzburg; results first posted 2019-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sunitinib in Refractory Adrenocortical Carcinoma. Trials, record NCT00453895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib in Refractory Adrenocortical Carcinoma
- NCT number
- NCT00453895
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of Wuerzburg
- Conditions
- Adrenocortical Carcinoma
- Interventions
- Sunitinib
- First posted
- 2007-03-29
- Last updated
- 2019-01-31
- Results first posted
- 2019-01-31
- Limitations and caveats
- A limitation arises from the fact that imaging prior study entry was not standardized. Therefore we cannot provide data regarding the dynamics of tumor growth before initiation of sunitinib.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Clinical Benefit Due to Treatment With Sunitinib | 12 weeks | Clinical benefit was defined as stable disease or better for at least 12 weeks |
| Secondary | Assessment of Objective Response Rates | 12 weeks | Objective Response Rate defined by RECIST 1.0 |
| Secondary | Assessment of Progression-free Survival | up to 400 days | Progression-free survival is defined as time of start of study until documentation of Progress. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Assessment of Overall Survival | up to 36 months | Overall Survival was defined as time from start of treatment until death or last follow-up. |
| Secondary | Assessment of Toxicity | up to 400 days | Adverse events were rated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (see http://ctep.cancer.gov/reporting/ctc.html). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessment of Clinical Benefit Due to Treatment With Sunitinib | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assessment of Objective Response Rates | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Assessment of Progression-free Survival | up to 400 days | days | MEDIAN | |
| SECONDARY | Assessment of Overall Survival | up to 36 months | monhts | MEDIAN | |
| SECONDARY | Assessment of Toxicity | up to 400 days | number of adverse events/patient | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessment of Clinical Benefit Due to Treatment With Sunitinib | Sunitinib | 5 | Participants | ||
| Assessment of Objective Response Rates | Sunitinib | 0 | Participants | ||
| Assessment of Progression-free Survival | Sunitinib | 83 | 95% Confidence Interval 80 to 85 | days | |
| Assessment of Overall Survival | Sunitinib | 5.4 | 95% Confidence Interval 3.2 to 7.6 | monhts | |
| Assessment of Toxicity | Sunitinib | 4 | Full Range 0 to 10 | number of adverse events/patient |
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 | Sunitinib | 39 | |
| Overall Study | COMPLETED | Sunitinib | 39 | |
| Overall Study | NOT COMPLETED | Sunitinib | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | Polyneuropathy | Nervous system disorders | Sunitinib | 10 | 39 | 11 |
| other | Pain | General disorders | Sunitinib | 10 | 39 | 15 |
| other | Diarrhea | Gastrointestinal disorders | Sunitinib | 9 | 39 | 9 |
| other | rash or discolored nails | Skin and subcutaneous tissue disorders | Sunitinib | 9 | 39 | 9 |
| other | fatigue | General disorders | Sunitinib | 3 | 39 | 3 |
| other | mucositis | Skin and subcutaneous tissue disorders | Sunitinib | 4 | 39 | 4 |
| other | Anemia, Thrombopenia, Leukopenia | Blood and lymphatic system disorders | Sunitinib | 4 | 39 | 4 |
| other | hemorrhage | Blood and lymphatic system disorders | Sunitinib | 3 | 39 | 3 |
| serious | myocard infarcton | Cardiac disorders | Sunitinib | 1 | 39 | 1 |
| serious | hypogylcimia | Endocrine disorders | Sunitinib | 1 | 39 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib | ||
| Total, other adverse events | Sunitinib | 39 | 39 |
| Total, serious adverse events | Sunitinib | 10 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22837187 | 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/NCT00453895
GET https://conductscience.org/api/trials/v1/NCT00453895/registered