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Trial · NCT00104871

Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

NCT00104871, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-06-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy. Trials, record NCT00104871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00104871

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
NCT number
NCT00104871
Status
Completed
Phases
Phase 2
Enrollment
24 participants, actual
Lead sponsor
National Cancer Institute (NCI)
Conditions
Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer
Interventions
Bortezomib
First posted
2005-03-04
Last updated
2018-12-19
Results first posted
2014-06-25

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryObjective Tumor Response Rate Assessed by RECISTBaseline to 12 weeks
Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
PrimaryParticipant Tumor Response Assessed by RECISTBaseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))
Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
SecondaryProgression-free Survival Assessed by RECISTAt 6 months
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

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYObjective Tumor Response Rate Assessed by RECISTBaseline to 12 weeksTwo participants were not evaluable for response.participantsNUMBER
PRIMARYParticipant Tumor Response Assessed by RECISTBaseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))Two participants were not evaluable for response.participantsNUMBER
SECONDARYProgression-free Survival Assessed by RECISTAt 6 monthsTwo participants were not evaluable for response.ParticipantsCOUNT_OF_PARTICIPANTS

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Objective Tumor Response Rate Assessed by RECISTBortezomib0participants
Participant Tumor Response Assessed by RECISTBortezomibComplete Response0participants
Participant Tumor Response Assessed by RECISTBortezomibPartial Response0participants
Participant Tumor Response Assessed by RECISTBortezomibStable Disease11participants
Participant Tumor Response Assessed by RECISTBortezomibProgressive Disease9participants
Progression-free Survival Assessed by RECISTBortezomib4Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDBortezomib22
Overall StudyCOMPLETEDBortezomib21
Overall StudyNOT COMPLETEDBortezomib1

Adverse events133

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAbdominal painGastrointestinal disordersBortezomib122
otherAcidosisMetabolism and nutrition disordersBortezomib122
otherAlanine aminotransferase increasedInvestigationsBortezomib322
otherAlkaline phosphatase increasedInvestigationsBortezomib222
otherAnemiaBlood and lymphatic system disordersBortezomib622
otherAnorexiaMetabolism and nutrition disordersBortezomib722
otherAnxietyPsychiatric disordersBortezomib422
otherArthralgiaMusculoskeletal and connective tissue disordersBortezomib122
otherArthritisMusculoskeletal and connective tissue disordersBortezomib122
otherAspartate aminotransferase increasedInvestigationsBortezomib122

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityBortezomib
Total, other adverse eventsBortezomib2222
Total, serious adverse eventsBortezomib1722

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00104871

GET https://conductscience.org/api/trials/v1/NCT00104871/events?page=2