Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005551

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary
and iodine-131 refractory, unresectable differentiated thyroid cancers.

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Brief Summary in Scientific Language

This will be an open-label study at approximately 50 study centers in the US, Europe and
other countries. The study will consist of a screening period (Pre-Treatment Phase), 28-day
treatment cycles (Treatment Phase), and a study termination/final visit and survival
follow-up. Patients showing clinical benefit will continue to receive the study drug
(Extension Phase) and will be followed up with the appropriate assessments.

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Organizational Data

  •   DRKS00005551
  •   2014/04/24
  •   2008/10/30
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00784303  (ClinicalTrials.gov)
  •   E7080-G000-201  (Eisai Inc.)
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Health Condition or Problem studied

  •   Thyroid Cancer
  •   C73 -  Malignant neoplasm of thyroid gland
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Interventions/Observational Groups

  •   Drug: E7080
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- Determine the effect of E7080 on the objective tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST).; time frame: Months 2, 4, 6, 8 and every two months thereafter.

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Secondary Outcome

- Adverse events, laboratory assessments, and electrocardiograms (ECGs).; time frame: AEs reported during all cycles; labs at each week in Cycle 1 and Day 1 at other cycles; ECGs at Day 1 of each cycle
- Progression-free survival, duration of response, and time to response.; time frame: At 12 weeks and 6 months
- Overall Survival.; time frame: At 6 and 12 months, every 3 months in 1st 2 years off study, every 6 months in Years 3 & 4, and yearly thereafter
- Pharmacokinetic profile.; time frame: Days 1 and 8 of Cycle 1 and Day 1 of other cycles

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Countries of Recruitment

  •   United States
  •   Australia
  •   France
  •   Germany
  •   Italy
  •   Poland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2009/08/31
  •   104
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion 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 criterion:

1. At least one lesion (≥ 1.5 cm in longest diameter for non-lymph nodes and ≥2.0
cm in longest diameter for lymph nodes) which is serially and accurately
measurable according to Modified Response Evaluation Criteria in Solid Tumors
(RECIST) using either computed tomography (CT) or magnetic resonance imaging
(MRI)

2. Lesions that have had electron beam radiotherapy must show evidence of
progressive disease based on Modified Response Evaluation Criteria in Solid
Tumors (RECIST) to be deemed a target lesion

3. Patients must show evidence of disease progression by Response Evaluation Criteria in
Solid Tumors (RECIST) using site assessment of computed tomography/magnetic resonance
imaging (CT/MRI) scans within 12 months (+1 month to allow for variances in patient
scanning intervals) prior to study entry.

4. Patients with Differentiated Thyroid Cancer (DTC) must be 131-I refractory/resistant:
never demonstrated 131-I uptake, 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.

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Exclusion Criteria

[---]*

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Eisai Inc.
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.