check_circleStudy Completed

Thyroid Neoplasms

Bayer Identifier:

17852

ClinicalTrials.gov Identifier:

NCT02303444

EudraCT Number:

Not Available

EU CT Number:

Not Available
An Observational Study in differentiated thyroid cancer which is radioactive iodine (RAI) refractory to assess the use of Multikinase inhibitors

Trial purpose

The purpose of the study was to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma)
    - DTC refractory to RAI
    - Radiological progression and preferably according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    - No symptoms due to DTC
    - >/=1cm diameter of lesion confirmed by radiological exam
    - Life expectancy of at least 6 months
  • - Plan to be treated according to a clinical trial protocol for intervention including a locoregional therapy or systemic therapy
    - Previous treatment with MKIs for advanced disease
    - Hospice patients

Trial summary

Enrollment Goal
667
Trial Dates
April 2015 - July 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, France
Completed
Many locations, Japan
Completed
Many locations, Spain
Completed
Many locations, Netherlands
Withdrawn
Many locations, Sweden
Withdrawn
Many locations, Denmark
Withdrawn
Many locations, Norway
Withdrawn
Many locations, Israel
Completed
Many locations, Argentina
Withdrawn
Many locations, Austria
Completed
Many locations, Turkey
Completed
Many locations, Greece
Completed
Many locations, Brazil
Completed
Many locations, Russia
Completed
Many locations, India
Completed
Many locations, Taiwan
Completed
Many locations, Algeria
Completed
Many locations, Egypt
Completed
Many locations, Saudi Arabia
Completed
Many locations, Lebanon
Withdrawn
Many locations, United Arab Emirates
Completed
Many locations, Mexico
Completed
Philadelphia, United States
Withdrawn
Many locations, Indonesia
Completed
Many locations, Philippines
Completed
Many Locations, Germany
Completed
Ann Arbor, United States
Completed
Washington, United States
Completed
Boston, United States
Completed
Bronx, United States
Completed
Atlanta, United States
Completed
Birmingham, United States
Completed
Torrance, United States
Withdrawn
Stony Brook, United States
Completed
Chicago, United States
Completed
Durham, United States
Completed
Dallas, United States
Completed
New Orleans, United States
Completed
Aurora, United States
Withdrawn
Charleston, United States
Withdrawn
Detroit, United States
Completed
Los Angeles, United States
Completed
Plantation, United States
Completed
Honolulu, United States
Completed
Philadelphia, United States

Primary Outcome

  • Time to symptomatic progression (TTSP) from study entry
    TTSP is defined as the time interval from the day of study entry to the date of first symptomatic progression. Patients who do not have a symptomatic progression at the time of analysis will be censored at the date of their last evaluable assessment.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival (OS) from time of study entry
    Defined as the time interval from the date of study entry to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Progression free survival (PFS) from time of study entry
    Defined as the time interval from the date of study entry to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • OS from time of being diagnosed as radioactive iodine (RAI) refractory
    Defined as the time interval from the day of being diagnosed as RAI refractory to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Post-progression survival (PPS) from time of symptomatic progression
    Defined as the time interval from the date of symptomatic progression to death due to any cause. Patients without symptomatic progression will be excluded from analysis and patients who are alive at the time of analysis will be censored at the last date when they were known to be alive.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • OS from initiation of the first Multikinase Inhibitor (MKI)
    Defined as the time interval from the day of start of the first MKI to death due to any cause. Patients alive at the time of analysis will be censored at the last date when they were known to be alive.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • PFS from initiation of first MKI
    Defined as the time interval from the day of start of first MKI to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • OS from initiation of any systemic treatment regimen
    Defined as the time interval from the date of start of any systemic treatment regimen to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • PFS from initiation of any systemic treatment regimen
    Defined as the time interval from the date of start of any systemic treatment regimen to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Duration of each systemic treatment regimen
    Defined as the time interval from the day of start of a treatment to the date of permanent discontinuation of a treatment (regardless of the reason for discontinuation including death). It includes interruption or drug holiday.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Response assessment to each systemic treatment regimen according to the categories “Complete Response", “Partial Response”, “Stable Disease”, “Clinical Progression”, “Radiological Progression”, and “Not evaluable at this visit”
    In case of “Clinical Progression” the CRF will ask for the presence of specific symptoms.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • OS from initiation of sorafenib
    Defined as the time interval from the day of start of sorafenib to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • PFS from initiation of sorafenib
    Defined as the time interval from the date of start of sorafenib to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Daily dose of sorafenib per patient throughout the treatment period
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of adverse events during treatment with sorafenib
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

RIFTOS MKI - Radioactive Iodine reFractory asymptomatic patients in differentiated Thyroid cancer – an Observational Study to assess the use of Multikinase Inhibitors
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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