Trial · NCT00434109
Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
NCT00434109, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2012-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization. Trials, record NCT00434109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00434109
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
- NCT number
- NCT00434109
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Neuroendocrine Tumor, Islet Cell Tumor
- Interventions
- Sunitinib malate, Hepatic Artery Embolizations
- First posted
- 2007-02-12
- Last updated
- 2012-09-14
- Results first posted
- 2012-09-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression Free Survival (PFS) at 12 Months | 12 months | Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started. |
| Secondary | Percentage of Participants With Overall Survival (OS) at One Year | 12 months | Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. |
| Secondary | Number of Participants With Partial Radiographic Response | 12 months | Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD. |
| Secondary | Number of Participants With Biochemical Response | 12 months | Biochemical response rate (\>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases. |
| Secondary | Number of Participants Requiring Dose Reduction | 12 months | Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects. |
| Secondary | Percentage of Participants With Overall Survival (OS) at 4 Years | 48 months | Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression Free Survival (PFS) at 12 Months | 12 months | All participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival (OS) at One Year | 12 months | All participants | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Partial Radiographic Response | 12 months | All Participants | participants | NUMBER |
| SECONDARY | Number of Participants With Biochemical Response | 12 months | All Participants | participants | NUMBER |
| SECONDARY | Number of Participants Requiring Dose Reduction | 12 months | All participants | participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival (OS) at 4 Years | 48 months | All Participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) at 12 Months | Sunitinib Malate and Hepatic Artery Embolizations | 66 | 95% Confidence Interval 51 to 81 | percentage of participants | |
| Percentage of Participants With Overall Survival (OS) at One Year | Sunitinib Malate and Hepatic Artery Embolizations | 95 | 95% Confidence Interval 88 to 100 | percentage of participants | |
| Number of Participants With Partial Radiographic Response | Sunitinib Malate and Hepatic Artery Embolizations | 28 | participants | ||
| Number of Participants With Biochemical Response | Sunitinib Malate and Hepatic Artery Embolizations | 19 | participants | ||
| Number of Participants Requiring Dose Reduction | Sunitinib Malate and Hepatic Artery Embolizations | 16 | participants | ||
| Percentage of Participants With Overall Survival (OS) at 4 Years | Sunitinib Malate and Hepatic Artery Embolizations | 59 | 95% Confidence Interval 38 to 80 | percentage of 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 | Sunitinib Malate and Hepatic Artery Embolizations | 39 | |
| Overall Study | COMPLETED | Sunitinib Malate and Hepatic Artery Embolizations | 21 | |
| Overall Study | NOT COMPLETED | Sunitinib Malate and Hepatic Artery Embolizations | 18 |
Source ClinicalTrials.gov
Adverse events40
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 | Hemoglobin | Blood and lymphatic system disorders | Sunitinib Malate and Hepatic Artery Embolizations | 22 | 39 | |
| other | Neutrophils/granulocytes | Blood and lymphatic system disorders | Sunitinib Malate and Hepatic Artery Embolizations | 19 | 39 | |
| other | Platelets | Blood and lymphatic system disorders | Sunitinib Malate and Hepatic Artery Embolizations | 14 | 39 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib Malate and Hepatic Artery Embolizations | 18 | 39 | |
| other | Anorexia | Gastrointestinal disorders | Sunitinib Malate and Hepatic Artery Embolizations | 11 | 39 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Sunitinib Malate and Hepatic Artery Embolizations | 7 | 39 | |
| other | Back pain | General disorders | Sunitinib Malate and Hepatic Artery Embolizations | 3 | 39 | |
| other | Constipation | Gastrointestinal disorders | Sunitinib Malate and Hepatic Artery Embolizations | 6 | 39 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sunitinib Malate and Hepatic Artery Embolizations | 4 | 39 | |
| other | Dehydration | Gastrointestinal disorders | Sunitinib Malate and Hepatic Artery Embolizations | 3 | 39 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib Malate and Hepatic Artery Embolizations | ||
| Total, other adverse events | Sunitinib Malate and Hepatic Artery Embolizations | 38 | 39 |
| Total, serious adverse events | Sunitinib Malate and Hepatic Artery Embolizations | 3 | 39 |
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/NCT00434109
GET https://conductscience.org/api/trials/v1/NCT00434109/events?page=2