Phase 2 N=52

Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

Thyroid Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00389441 ↗

Enrolled (actual)

Serious AEs

42.3%

Results posted

Nov 2013

Primary outcome: Primary: Percentage of Participants With Objective Response (OR) — 34.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AG-013736 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Sep 2012

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	—

Summary

The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

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.

View full record on ClinicalTrials.gov →

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.