Trial · NCT00519896
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
NCT00519896, Phase 2, Completed, University of Washington; results first posted 2017-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer. Trials, record NCT00519896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00519896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
- NCT number
- NCT00519896
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer, Stage IVB Follicular Thyroid Cancer, Stage IVB Papillary Thyroid Cancer, Stage IVC Follicular Thyroid Cancer, Stage IVC Papillary Thyroid Cancer, Thyroid Gland Medullary Carcinoma
- Interventions
- sunitinib malate
- First posted
- 2007-08-23
- Last updated
- 2017-04-25
- Results first posted
- 2017-04-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", |
| Secondary | Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years | Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded. |
| Secondary | Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease | At 30 days from the last dose of study treatment and then for 2 years | 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. |
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 | Overall Response Rate | At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years | All patients that received at least one dose of sunitinib malate were included in the analysis. | participants | NUMBER |
| SECONDARY | Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease | At 30 days from the last dose of study treatment and then for 2 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 11 | Participants | ||
| Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | Fatigue | 4 | participants | |
| Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | Neutropenia | 12 | participants | |
| Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | Hand/Foot syndrome | 6 | participants | |
| Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | Diarrhea | 6 | participants | |
| Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | Leukopenia | 11 | participants | |
| Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | Gastrointestional Hemorrhage | 1 | participants | |
| Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 12.8 | 95% Confidence Interval 8.9 to NA | months |
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 | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 35 | |
| Overall Study | COMPLETED | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 33 | |
| Overall Study | NOT COMPLETED | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 2 |
Source ClinicalTrials.gov
Adverse events21
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 | General disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 9 | 35 | 9 |
| other | Dehydration | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 2 | 35 | 2 |
| other | Anorexia | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 1 | 35 | 1 |
| other | Mucositis | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 2 | 35 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 9 | 35 | 9 |
| other | Nausea/vomiting | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 3 | 35 | 3 |
| other | Odynophagia | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 2 | 35 | 2 |
| other | Gastrointestional Bleed | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 5 | 35 | 5 |
| other | Hand/Foot Syndrome | Skin and subcutaneous tissue disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 9 | 35 | 9 |
| other | Hemoptysis | Blood and lymphatic system disorders | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 2 | 35 | 2 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | ||
| Total, other adverse events | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 35 | 35 |
| Total, serious adverse events | Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy) | 1 | 35 |
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/NCT00519896
GET https://conductscience.org/api/trials/v1/NCT00519896/events?page=2