Phase 2
Completed N=52
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
Source: ClinicalTrials.gov NCT00389441 ↗Enrolled (actual)
52
Serious AEs
42.3%
Results posted
Nov 2013
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 34.6 percentage of participants
Summary
The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
34.6 | — |
| SECONDARY Progression Free Survival (PFS) |
70.14 | — |
| SECONDARY Duration of Response (DR) |
74.71 | — |
| SECONDARY Overall Survival (OS) |
118.43 | — |
| SECONDARY Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score |
1.66; 0.18; 0.43; 0.52; 0.53; 0.58 | — |
| SECONDARY Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score |
2.24; -0.05; 0.28; 0.67; 0.46; 0.47 | — |
Eligibility Criteria
Inclusion Criteria
- Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
- At least 1 measurable target lesion, as defined by RECIST
Exclusion Criteria
- Thyroid lymphoma
- Previous treatment with anti-angiogenesis agents
- No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.
Data sourced from ClinicalTrials.gov (NCT00389441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.