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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000002280
• Date of registration: 06/01/2009
• Prospective Registration: No
• Primary sponsor: Eisai Inc
• Public title: Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
• Scientific title: 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
• Date of first enrolment: 01/10/2008
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12609000002280.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 2

Countries of recruitment

Australia, France, Germany, Italy, Poland, United Kingdom, United States of America

Contacts

• Name: Dr Corina Andresen

• Name: Teng Fong Chin

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Thyroid Cancer;
Thyroid Cancer

Cancer - Thyroid

Intervention(s)

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.

Primary Outcome(s)

Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST).[Months 2, 4, 6, 8 and every two months until all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]

Secondary Outcome(s)

Determine the time to response (CR or PR) by IIR.[When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]

Assess the influence of CYP3A4, CYP1A2, and CYP2B6 genotype on E7080 PK.[When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]

Determine the effect of E7080 on duration of response by IIR.[When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]

Evaluate the effect of E7080 on progression free survival (PFS: at 12 weeks and 6 months) by IIR and overall survival (OS: at 6 months and 12 months).[When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]

Evaluate the safety and tolerability of E7080.
Safety will be assessed by all adverse events(AEs) (Any untoward medical occurrence in a patient or clinical investigation patient administered an investigational product. An adverse event does not necessarily have a causal relationship with the medicinal product. For this study the medicinal product is E7080.) and serious adverse events (SAEs); regular vital signs measurements and physical examinations; Holter monitoring; 12-lead electrocardiogram (ECG) and echocardiogram evaluations; and regular monitoring of hematology, biochemistry and urinalysis values.)[When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.]

Secondary ID(s)

ClinicalTrials.gov Identifier: NCT00784303

Source(s) of Monetary Support

Eisai Inc

Secondary Sponsor(s)

Eisai Limited

Ethics review

Status: Approved
Approval date:
Contact:

Quorum Review