Trial · NCT00389441
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
NCT00389441, Phase 2, Completed, Pfizer; results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer. Trials, record NCT00389441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00389441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
- NCT number
- NCT00389441
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Thyroid Neoplasms
- Interventions
- AG-013736
- First posted
- 2006-10-18
- Last updated
- 2013-11-25
- Results first posted
- 2013-11-25
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 disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (\>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study \>=4 weeks after initial documentation of response. |
| Secondary | Progression Free Survival (PFS) | Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up) | PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Duration of Response (DR) | Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up) | Time in weeks 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. 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 2 year after the first dose for the last participant | Time in weeks 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) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Secondary | Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up) | Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome. |
| Secondary | Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score | Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up) | Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome. |
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 disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up) | Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up) | ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. | weeks | MEDIAN |
| SECONDARY | Duration of Response (DR) | Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up) | Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR). | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline to death due to any cause or at least 2 year after the first dose for the last participant | ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. | weeks | MEDIAN |
| SECONDARY | Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up) | ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score | Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up) | ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group134
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 | 34.6 | 95% Confidence Interval 22.0 to 49.1 | percentage of participants | |
| Progression Free Survival (PFS) | Axitinib | 70.14 | 95% Confidence Interval 64.14 to 93.71 | weeks | |
| Duration of Response (DR) | Axitinib | 74.71 | 95% Confidence Interval 59.14 to 112.29 | weeks | |
| Overall Survival (OS) | Axitinib | 118.43 | 95% Confidence Interval 63.57 to 174.57 | weeks | |
| Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Axitinib | Baseline (n= 49) | 1.66 | Standard Deviation 1.301 | units on a scale |
| Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Axitinib | Change at C1D15 (n= 40) | 0.18 | Standard Deviation 1.158 | units on a scale |
| Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Axitinib | Change at C2D1 (n= 42) | 0.43 | Standard Deviation 1.274 | units on a scale |
| Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Axitinib | Change at C2D15 (n= 37) | 0.52 | Standard Deviation 1.407 | units on a scale |
| Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Axitinib | Change at C3D1 (n= 43) | 0.53 | Standard Deviation 1.602 | units on a scale |
| Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score | Axitinib | Change at C4D1 (n= 39) | 0.58 | Standard Deviation 1.199 | units on a scale |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Axitinib | 52 | |
| Overall Study | COMPLETED | Axitinib | 0 | |
| Overall Study | NOT COMPLETED | Axitinib | 52 |
Source ClinicalTrials.gov
Adverse events255
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 | 3 | 52 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Leukopenia | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Neutropenia | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Paratracheal lymphadenopathy | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Axitinib | 1 | 52 | |
| other | Atrial thrombosis | Cardiac disorders | Axitinib | 1 | 52 | |
| other | Sinus bradycardia | Cardiac disorders | Axitinib | 1 | 52 |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 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 | 52 | 52 |
| Total, serious adverse events | Axitinib | 22 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24844950 | 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/NCT00389441
GET https://conductscience.org/api/trials/v1/NCT00389441/results?page=2