Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Phase II, Multicenter, Open-Label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000002280

Enrollment

100

Registered

2009-01-06

Start date

2008-10-01

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose is to determine the effect of E7080 on the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) by independent imaging review (IIR) and determine the pharmacokinetic (PK) profile and pharmacokinetic/ pharmacodynamic (PK/PD) relationships in the patients with medullary thyroid cancer [MTC] or radioiodine (131I) refractory/resistant differentiated thyroid cancer[DTC].

Interventions

E7080 given orally continuously at 10 mg, twice a day for 28 days (one cycle) until the evidence of disease progression, unacceptable toxicity, death or if the patient withdraws consent,etc.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1.Patients must have histologically or cytologically confirmed diagnosis of Medullary Thyroid Cancer (MTC) or Differentiated Thyroid Cancer (DTC). 2.Measurable disease meeting the following criteria: -- Radiographically measurable disease defined as at least one lesion that can be accurately measured in 1 dimension as at least 20 mm by conventional Computed tomography (CT) or magnetic resonance imaging (MRI) techniques or as at least 10 mm by spiral CT scan. 3.Patients must show evidence of disease progression by RECIST using site assessment of CT/MRI scans within 6 months (+ 1 month to allow for variances in patients scanning intervals) prior to study entry. 4.Patients with DTC must be 131-I refractory/resistant disease: never demonstrated 131-I uptake or progression despite 131-I uptake, or cumulative dose of 131-I of > 600 mCi (last dose given at least 6 months prior to study entry). 5.Well controlled blood pressure prior to study entry. 6.Signed informed consent.

Exclusion criteria

1.Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid 2.Brain or leptomeningeal metastases 3.Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina or myocardial infarction within 6 months of study start, or serious cardiac arrhythmia) 4.Marked baseline prolongation of QT/QTc interval 5.Proteinuria > 1+ or > 30 mg in dipstick testing 6.Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry

Outcome results