Trial · NCT00118248
Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
NCT00118248, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer. Trials, record NCT00118248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
- NCT number
- NCT00118248
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer, Thyroid Gland Medullary Carcinoma
- Interventions
- tanespimycin
- First posted
- 2005-07-11
- Last updated
- 2017-02-15
- Results first posted
- 2014-05-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) | 1 year | The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval. 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. Patients that are not classified as having a progression are termed progression-free. |
| Secondary | Overall Response | Baseline, every 3 courses, and at the end of treatment study | The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0. Complete Response (CR): Disappearance of all lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD. |
| Secondary | Progression-Free Survival | Every 3 months for up to 3 years | Defined as the time from registration to the date of progression or death due to any cause. 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. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival | Every 3 months until progression, and then every 6 months up to 3 years | Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method. |
| Secondary | Toxicity | Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles) | Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
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 | Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) | 1 year | All patients were evaluable for this endpoint in this group. | percentage of participants | NUMBER |
| SECONDARY | Overall Response | Baseline, every 3 courses, and at the end of treatment study | All participants were evaluated for response. | participants | NUMBER |
| SECONDARY | Progression-Free Survival | Every 3 months for up to 3 years | All participants were evaluable for this endpoint. | months | MEDIAN |
| SECONDARY | Overall Survival | Every 3 months until progression, and then every 6 months up to 3 years | All patients were evaluable for this endpoint. | years | MEDIAN |
| SECONDARY | Toxicity | Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles) | All participants were evaluable for this endpoint. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) | Advanced Medullary Thyroid Carcinoma Group | 5.9 | 90% Confidence Interval 0.3 to 25.0 | percentage of participants | |
| Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin) | Differentiated Thyroid Carcinoma | 12.5 | 90% Confidence Interval 3.5 to 29.2 | percentage of participants | |
| Overall Response | Advanced Medullary Thyroid Carcinoma Group | Complete Response (CR) | 0 | participants | |
| Overall Response | Differentiated Thyroid Carcinoma | Complete Response (CR) | 0 | participants | |
| Overall Response | Advanced Medullary Thyroid Carcinoma Group | Partial Response (PR) | 1 | participants | |
| Overall Response | Differentiated Thyroid Carcinoma | Partial Response (PR) | 0 | participants | |
| Progression-Free Survival | Advanced Medullary Thyroid Carcinoma Group | 6.4 | 95% Confidence Interval 2.7 to 17.2 | months | |
| Progression-Free Survival | Differentiated Thyroid Carcinoma | 4.1 | 95% Confidence Interval 2.2 to 8.7 | months | |
| Overall Survival | Advanced Medullary Thyroid Carcinoma Group | 2.1 | 95% Confidence Interval 0.67 to 3.1 | years | |
| Overall Survival | Differentiated Thyroid Carcinoma | 1.5 | 95% Confidence Interval 0.73 to 3.5 | years |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Advanced Medullary Thyroid Carcinoma Group | 17 | |
| Overall Study | STARTED | Differentiated Thyroid Carcinoma | 24 | |
| Overall Study | COMPLETED | Advanced Medullary Thyroid Carcinoma Group | 17 | |
| Overall Study | COMPLETED | Differentiated Thyroid Carcinoma | 24 | |
| Overall Study | NOT COMPLETED | Advanced Medullary Thyroid Carcinoma Group | 0 | |
| Overall Study | NOT COMPLETED | Differentiated Thyroid Carcinoma | 0 |
Source ClinicalTrials.gov
Adverse events120
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 decreased | Blood and lymphatic system disorders | All Patients | 24 | 41 | 104 |
| other | Lymph node pain | Blood and lymphatic system disorders | All Patients | 2 | 41 | 3 |
| other | Cardiac disorder | Cardiac disorders | All Patients | 1 | 41 | 1 |
| other | Ear disorder | Ear and labyrinth disorders | All Patients | 1 | 41 | 1 |
| other | Ear pain | Ear and labyrinth disorders | All Patients | 1 | 41 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | All Patients | 1 | 41 | 11 |
| other | Tinnitus | Ear and labyrinth disorders | All Patients | 1 | 41 | 12 |
| other | Hypothyroidism | Endocrine disorders | All Patients | 1 | 41 | 4 |
| other | Photophobia | Eye disorders | All Patients | 1 | 41 | 1 |
| other | Constipation | Gastrointestinal disorders | All Patients | 2 | 41 | 13 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | All Patients | 39 | 41 |
| Total, serious adverse events | All Patients | 13 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00118248
GET https://conductscience.org/api/trials/v1/NCT00118248/events?page=2