Trial · NCT00625846
Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
NCT00625846, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer. Trials, record NCT00625846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00625846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
- NCT number
- NCT00625846
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 152 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Thyroid Gland Carcinoma, Stage III Differentiated Thyroid Gland Carcinoma AJCC v7, Stage III Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v7, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v7, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7, Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v7, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7, Thyroid Gland Anaplastic Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Pazopanib Hydrochloride
- First posted
- 2008-02-28
- Last updated
- 2020-02-26
- Results first posted
- 2020-02-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (in Cohorts 1-3) | Up to 3 years | The tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients in Cohorts 1-3. 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. |
| Primary | Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort) | Up to 3 years | The confirmed tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients with differentiated thyroid cancer who are thyroglobulin antibody negative. 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 | Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment | Up to 3 years | Toxicity (defined as grade 3+ adverse events deemed possibly, probably, or definitely related to treatment) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The percentage of patients with grade 3+ adverse events deemed possibly, probably, or definitely related to treatment are reported for patients in Cohorts 1-3. |
| Secondary | Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only) | Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 6 months | Progression free survival at 6 months (PFS6) is defined as the proportion of patients alive and without progression at 6 months. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. |
| Secondary | Progression-Free Survival at 3 Months (Cohort 3 Only) | Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 months | Progression free survival at 3 months (PFS6) is defined as the proportion of patients alive and without progression at 3 months. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. |
| Other | Change in Blood Markers for Angiogenesis | Baseline to up to 3 years | Blood markers for angiogenesis including levels of free VEGF, free GW786034, and GW786034/VEGF complexes will be evaluated before and during therapy. Changes in these levels will largely be explored in a graphical manner as well as exploring any potential relationships between these levels and clinical outcome such as response or progression-free rate and toxicity incidence. |
| Other | Proportion of Patients With Differentiated Thyroid Cancer and Medullary Thyroid Cancer Who Have Not Failed Treatment at 6 Months (3 Months for Anaplastic Thyroid Cancer) | Up to 6 months | The proportion of patients who have not failed treatment due to disease progression, adverse reactions, refusal for further participation, or who went on to alternate therapy at 6 months (3 months for anaplastic thyroid cancer patients) will be calculated and summarized independently within each of the patient groups. Assuming that the incidence of response is binomially distributed, 90% binomial confidence intervals will also be calculated. |
| Other | Overall Survival | Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years | Overall survival time is defined as the time from registration to death due to any cause. The median is estimated using the Kaplan-Meier estimator.\> Estimated using the method of Kaplan-Meier. |
| Other | Time to Treatment Failure | Time from registration to the date the patient discontinues treatment, assessed up to 3 years | Estimated using the method of Kaplan-Meier. |
| Other | Time to Subsequent Therapy | Up to 3 years | Estimated using the method of Kaplan-Meier. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (in Cohorts 1-3) | Up to 3 years | All patients in Cohort 1, Cohort 2, and Cohort 3 that received treatment and were eligible for response assessment were included in this analysis. | percentage of participants | NUMBER |
| PRIMARY | Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort) | Up to 3 years | All patients that registered to the Differential Thyroid Expansion cohort and were evaluable for response assessment were included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment | Up to 3 years | All patients that received protocol treatment and were assessed for adverse events are included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only) | Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 6 months | All patients in Cohort 1 and Cohort 2 that received treatment and were eligible for response assessment were included in this analysis. | proportion of participants | NUMBER |
| SECONDARY | Progression-Free Survival at 3 Months (Cohort 3 Only) | Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 months | All patients from Cohort 3 that were treated and evaluable for response were included in this analysis. | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change in Blood Markers for Angiogenesis | Baseline to up to 3 years | |||
| OTHER_PRE_SPECIFIED | Proportion of Patients With Differentiated Thyroid Cancer and Medullary Thyroid Cancer Who Have Not Failed Treatment at 6 Months (3 Months for Anaplastic Thyroid Cancer) | Up to 6 months | |||
| OTHER_PRE_SPECIFIED | Overall Survival | Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years | |||
| OTHER_PRE_SPECIFIED | Time to Treatment Failure | Time from registration to the date the patient discontinues treatment, assessed up to 3 years | |||
| OTHER_PRE_SPECIFIED | Time to Subsequent Therapy | Up to 3 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (in Cohorts 1-3) | Cohort 1 (DTC) | 49 | 95% Confidence Interval 35 to 68 | percentage of participants | |
| Overall Response Rate (in Cohorts 1-3) | Cohort 2 (MTC) | 14 | 95% Confidence Interval 6 to 28 | percentage of participants | |
| Overall Response Rate (in Cohorts 1-3) | Cohort 3 (ATC) | 0 | 95% Confidence Interval 0 to 22 | percentage of participants | |
| Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort) | Expansion Cohort (DTC) | 37 | 95% Confidence Interval 25 to 50 | percentage of participants | |
| Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment | Cohort 1 (DTC) | 40 | percentage of participants | ||
| Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment | Cohort 2 (MTC) | 46 | percentage of participants | ||
| Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment | Cohort 3 (ATC) | 53 | percentage of participants | ||
| Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment | Expansion Cohort (DTC) | 53 | percentage of participants | ||
| Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only) | Cohort 1 (DTC) | .71 | 95% Confidence Interval .58 to .87 | proportion of participants | |
| Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only) | Cohort 2 (MTC) | .686 | 95% Confidence Interval .548 to .858 | proportion of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (DTC) | 39 | |
| Overall Study | STARTED | Cohort 2 (MTC) | 35 | |
| Overall Study | STARTED | Cohort 3 (ATC) | 16 | |
| Overall Study | STARTED | Expansion Cohort (DTC) | 62 | |
| Overall Study | COMPLETED | Cohort 1 (DTC) | 37 | |
| Overall Study | COMPLETED | Cohort 2 (MTC) | 35 | |
| Overall Study | COMPLETED | Cohort 3 (ATC) | 15 | |
| Overall Study | COMPLETED | Expansion Cohort (DTC) | 60 | |
| Overall Study | NOT COMPLETED | Cohort 1 (DTC) | 2 | |
| Overall Study | NOT COMPLETED | Cohort 2 (MTC) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events944
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 | Cohort 1 (DTC) | 17 | 38 | 70 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Cohort 2 (MTC) | 14 | 35 | 103 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Cohort 3 (ATC) | 7 | 15 | 11 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Expansion Cohort (DTC) | 33 | 61 | 182 |
| other | Palpitations | Cardiac disorders | Cohort 1 (DTC) | 1 | 38 | 5 |
| other | Palpitations | Cardiac disorders | Cohort 2 (MTC) | 0 | 35 | 0 |
| other | Palpitations | Cardiac disorders | Cohort 3 (ATC) | 0 | 15 | 0 |
| other | Palpitations | Cardiac disorders | Expansion Cohort (DTC) | 0 | 61 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Cohort 1 (DTC) | 0 | 38 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Cohort 2 (MTC) | 0 | 35 | 0 |
1 to 10 of 944Source ClinicalTrials.gov
See all 944 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (DTC) | 3 | 38 |
| Total, all-cause mortality | Cohort 2 (MTC) | 0 | 35 |
| Total, all-cause mortality | Cohort 3 (ATC) | 1 | 15 |
| Total, all-cause mortality | Expansion Cohort (DTC) | 4 | 61 |
| Total, other adverse events | Cohort 1 (DTC) | 38 | 38 |
| Total, other adverse events | Cohort 2 (MTC) | 35 | 35 |
| Total, other adverse events | Cohort 3 (ATC) | 15 | 15 |
| Total, other adverse events | Expansion Cohort (DTC) | 59 | 61 |
| Total, serious adverse events | Cohort 1 (DTC) | 21 | 38 |
| Total, serious adverse events | Cohort 2 (MTC) | 18 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00625846
GET https://conductscience.org/api/trials/v1/NCT00625846/events?page=2