Trial · NCT00094055
Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
NCT00094055, Phase 2, Completed, Pfizer; results first posted 2012-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer. Trials, record NCT00094055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094055
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
- NCT number
- NCT00094055
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Thyroid Neoplasms
- Interventions
- AG013736
- First posted
- 2004-10-11
- Last updated
- 2012-06-26
- Results first posted
- 2012-03-30
- Limitations and caveats
Population pharmacokinetics and plasma concentrations of soluble proteins were not presented, as the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.
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 Objective Response (OR) | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Progression-Free Survival (PFS) | Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks | Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death"). |
| Secondary | Duration of Response (DR) | Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks | Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Secondary | Overall Survival (OS) | Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant | Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact. |
| Other | Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations | Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks | Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations. |
| Other | Plasma Concentrations of Soluble Proteins | Day 1 (pre-dose) and then every 8 weeks up to 206 weeks | Plasma concentrations of soluble proteins (vascular endothelial growth factor \[VEGF\], placental growth factor \[PlGF\] and soluble vascular endothelial growth factor receptor-2 \[sVEGFR2\]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline. |
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 Objective Response (OR) | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks | Intent to treat (ITT) population included all participants who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks | ITT population included all participants who received at least 1 dose of study medication. | Days | MEDIAN |
| SECONDARY | Duration of Response (DR) | Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks | Subgroup of participants from the ITT population with a confirmed objective tumor response (CR or PR). | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant | ITT population included all participants who received at least 1 dose of study medication. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations | Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks | Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report. | nanogram/milliliter (ng/mL) | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentrations of Soluble Proteins | Day 1 (pre-dose) and then every 8 weeks up to 206 weeks | Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report. | Ratio | MEAN |
Source ClinicalTrials.gov
Results by group4
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 Objective Response (OR) | Axitinib | 38.3 | 95% Confidence Interval 26.1 to 51.8 | Percentage of participants | |
| Progression-Free Survival (PFS) | Axitinib | 459 | 95% Confidence Interval 302 to 610 | Days | |
| Duration of Response (DR) | Axitinib | 625 | 95% Confidence Interval 382 to 1391 | Days | |
| Overall Survival (OS) | Axitinib | 1068 | 95% Confidence Interval 568 to NA | Days |
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 | Axitinib | 60 | |
| Overall Study | COMPLETED | Axitinib | 0 | |
| Overall Study | NOT COMPLETED | Axitinib | 60 |
Source ClinicalTrials.gov
Adverse events183
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 | Anaemia | Blood and lymphatic system disorders | Axitinib | 5 | 60 | |
| other | Leukopenia | Blood and lymphatic system disorders | Axitinib | 3 | 60 | |
| other | Neutropenia | Blood and lymphatic system disorders | Axitinib | 4 | 60 | |
| other | Atrial fibrillation | Cardiac disorders | Axitinib | 3 | 60 | |
| other | Palpitations | Cardiac disorders | Axitinib | 5 | 60 | |
| other | Tachycardia | Cardiac disorders | Axitinib | 4 | 60 | |
| other | Ear pain | Ear and labyrinth disorders | Axitinib | 4 | 60 | |
| other | Vision blurred | Eye disorders | Axitinib | 3 | 60 | |
| other | Abdominal distension | Gastrointestinal disorders | Axitinib | 7 | 60 | |
| other | Abdominal pain | Gastrointestinal disorders | Axitinib | 16 | 60 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Axitinib | ||
| Total, other adverse events | Axitinib | 60 | 60 |
| Total, serious adverse events | Axitinib | 32 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25315258 | DERIVED |
Source PubMed
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/NCT00094055
GET https://conductscience.org/api/trials/v1/NCT00094055/events?page=2