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Trial registered on ANZCTR


Registration number
ACTRN12609000002280
Ethics application status
Approved
Date submitted
26/11/2008
Date registered
6/01/2009
Date last updated
18/01/2012
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 761 0
ClinicalTrials.gov Identifier: NCT00784303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Cancer 4031 0
Condition category
Condition code
Cancer 4234 4234 0 0
Thyroid

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3752 0
Treatment: Drugs
Comparator / control treatment
No comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5122 0
Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST).
Timepoint [1] 5122 0
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 [1] 8625 0
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.)
Timepoint [1] 8625 0
When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.
Secondary outcome [2] 8787 0
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).
Timepoint [2] 8787 0
When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.
Secondary outcome [3] 8788 0
Determine the effect of E7080 on duration of response by IIR.
Timepoint [3] 8788 0
When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.
Secondary outcome [4] 8789 0
Determine the time to response (CR or PR) by IIR.
Timepoint [4] 8789 0
When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.
Secondary outcome [5] 8790 0
Assess the influence of CYP3A4, CYP1A2, and CYP2B6 genotype on E7080 PK.
Timepoint [5] 8790 0
When all participants have completed 8 cycles of treatment or are off study treatment which ever occurs first.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1316 0
3004, 2065, 4029
Recruitment outside Australia
Country [1] 1411 0
United States of America
State/province [1] 1411 0
Country [2] 1412 0
France
State/province [2] 1412 0
Country [3] 1413 0
United Kingdom
State/province [3] 1413 0
Country [4] 1414 0
Germany
State/province [4] 1414 0
Country [5] 1415 0
Italy
State/province [5] 1415 0
Country [6] 1416 0
Poland
State/province [6] 1416 0

Funding & Sponsors
Funding source category [1] 4211 0
Commercial sector/Industry
Name [1] 4211 0
Eisai Inc
Address [1] 4211 0
300 Tice Boulevard WoodCliff Lake NJ 07677
Country [1] 4211 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc
Address
300 Tice Boulevard WoodCliff Lake NJ 07677
Country
United States of America
Secondary sponsor category [1] 3785 0
Commercial sector/Industry
Name [1] 3785 0
Eisai Limited
Address [1] 3785 0
European Knowledge Centre
Mosquito Way Hatfield Hertfordshire AL10 9SN
Country [1] 3785 0
United Kingdom
Other collaborator category [1] 496 0
Commercial sector/Industry
Name [1] 496 0
PPD Australia Pty Ltd
Address [1] 496 0
Level 9, 5 Queens Rd, Melbourne VIC 3004
Country [1] 496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6264 0
Quorum Review
Ethics committee address [1] 6264 0
Suite 1000, 1601 Fifth Avenue, Seattle, WA, US 98101
Ethics committee country [1] 6264 0
United States of America
Date submitted for ethics approval [1] 6264 0
11/09/2008
Approval date [1] 6264 0
18/09/2008
Ethics approval number [1] 6264 0
00003226

Summary
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].
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29168 0
Address 29168 0
Country 29168 0
Phone 29168 0
Fax 29168 0
Email 29168 0
Contact person for public queries
Name 12325 0
Teng Fong Chin
Address 12325 0
152 Beach Road #15-05 to 08 Gateway east 189721
Country 12325 0
Singapore
Phone 12325 0
+65 6297 6624
Fax 12325 0
Email 12325 0
t-chin@ecs.eisai.com.sg
Contact person for scientific queries
Name 3253 0
Dr Corina Andresen
Address 3253 0
300 Tice Boulevard WoodCliff Lake NJ 07677
Country 3253 0
United States of America
Phone 3253 0
+1 201 949-4069
Fax 3253 0
Email 3253 0
Corina_Andresen@eisai.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary