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An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors (RIFTOS MKI)

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ClinicalTrials.gov Identifier: NCT02303444
Recruitment Status : Active, not recruiting
First Posted : December 1, 2014
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of the study is 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.

Condition or disease Intervention/treatment
Thyroid Neoplasms Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Other Multikinase inhibitors

Detailed Description:
The primary objective of this study is to compare time to symptomatic progression (TTSP) from study entry in asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry with that of asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry.

Study Type : Observational
Actual Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
Actual Study Start Date : April 8, 2015
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MKI patients
Asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry. For patients on sorafenib, treatment start and stop dates will be collected along with any adverse events observed.
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.

Drug: Other Multikinase inhibitors
Patients can get MKIs at any time during study.

non-MKI patients
Asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry. For patients on sorafenib, treatment start and stop dates will be collected along with any adverse events observed.
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.

Drug: Other Multikinase inhibitors
Patients can get MKIs at any time during study.




Primary Outcome Measures :
  1. Time to symptomatic progression (TTSP) from study entry [ Time Frame: Up to 6 years ]
    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.


Secondary Outcome Measures :
  1. Overall survival (OS) from time of study entry [ Time Frame: Up to 6 years ]
    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.

  2. Progression free survival (PFS) from time of study entry [ Time Frame: Up to 6 years ]
    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.

  3. OS from time of being diagnosed as radioactive iodine (RAI) refractory [ Time Frame: Up to 6 years ]
    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.

  4. Post-progression survival (PPS) from time of symptomatic progression [ Time Frame: Up to 6 years ]
    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.

  5. OS from initiation of the first Multikinase Inhibitor (MKI) [ Time Frame: Up to 6 years ]
    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.

  6. PFS from initiation of first MKI [ Time Frame: Up to 6 years ]
    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.

  7. OS from initiation of any systemic treatment regimen [ Time Frame: Up to 6 years ]
    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.

  8. PFS from initiation of any systemic treatment regimen [ Time Frame: Up to 6 years ]
    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.

  9. Duration of each systemic treatment regimen [ Time Frame: Up to 6 years ]
    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.

  10. 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" [ Time Frame: Up to 6 years ]
    In case of "Clinical Progression" the CRF will ask for the presence of specific symptoms.

  11. OS from initiation of sorafenib [ Time Frame: Up to 6 years ]
    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.

  12. PFS from initiation of sorafenib [ Time Frame: Up to 6 years ]
    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.

  13. Daily dose of sorafenib per patient throughout the treatment period [ Time Frame: Up to 6 years ]
  14. Number of adverse events during treatment with sorafenib [ Time Frame: Up to 6 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any setting that provides treatment for progressive asymptomatic RAI refractory DTC
Criteria

Inclusion Criteria:

  • Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma)
  • DTC refractory to RAI
  • Radiological progression and preferably according to RECIST 1.1
  • No symptoms due to DTC
  • >/=1cm diameter of lesion confirmed by radiological exam
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303444


  Show 36 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02303444     History of Changes
Other Study ID Numbers: 17852
NX1401 ( Other Identifier: Company internal )
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Keywords provided by Bayer:
Progressive radioactive iodine refractory differentiated thyroid carcinoma

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Sorafenib
Iodine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs