Clinical Trial - NCT02303444

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

Active, not recruiting

Sponsor: Bayer

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02303444

Protocol Info

Short Description: RIFTOS MKI For Differentiated Thyroid cancer
Long Description: RIFTOS MKI - Radioactive Iodine reFractory asymptomatic patients in differentiated Thyroid cancer – an Observational Study to assess the use of MultiKinase Inhibitors
MGH Status: Open
Sponsor: Bayer
Disease Program: Head & Neck

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Thyroid Neoplasms Sorafenib (Nexavar, BAY43-9006) Other Multikinase inhibitors
Study Type Observational
Official Title RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors

Primary Outcome Measures

Time to symptomatic progression (TTSP) from study entry [Time Frame: Up to 6 years] [Designated as safety issue: ]


Secondary Outcome Measures

Overall survival (OS) from time of study entry [Time Frame: Up to 6 years] [Designated as safety issue: ]

Progression free survival (PFS) from time of study entry [Time Frame: Up to 6 years] [Designated as safety issue: ]

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

Post-progression survival (PPS) from time of symptomatic progression [Time Frame: Up to 6 years] [Designated as safety issue: ]

OS from initiation of the first Multikinase Inhibitor (MKI) [Time Frame: Up to 6 years] [Designated as safety issue: ]

PFS from initiation of first MKI [Time Frame: Up to 6 years] [Designated as safety issue: ]

OS from initiation of any systemic treatment regimen [Time Frame: Up to 6 years] [Designated as safety issue: ]

PFS from initiation of any systemic treatment regimen [Time Frame: Up to 6 years] [Designated as safety issue: ]

Duration of each systemic treatment regimen [Time Frame: Up to 6 years] [Designated as safety issue: ]

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] [Designated as safety issue: ]

OS from initiation of sorafenib [Time Frame: Up to 6 years] [Designated as safety issue: ]

PFS from initiation of sorafenib [Time Frame: Up to 6 years] [Designated as safety issue: ]

Daily dose of sorafenib per patient throughout the treatment period [Time Frame: Up to 6 years] [Designated as safety issue: ]

Number of adverse events during treatment with sorafenib [Time Frame: Up to 6 years] [Designated as safety issue: ]

Estimated Enrollment: 661
Study Start Date: April 2015
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: March 2020
Arms Assigned Interventions

: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: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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02303444

Locations

  • United States, Alabama
    • Birmingham, Alabama, United States,
  • United States, California
    • Los Angeles, California, United States,
    • Torrance, California, United States,
  • United States, Colorado
    • Aurora, Colorado, United States,
  • United States, District of Columbia
    • Washington, District of Columbia, United States,
  • United States, Florida
    • Plantation, Florida, United States,
  • United States, Georgia
    • Atlanta, Georgia, United States,
  • United States, Hawaii
    • Honolulu, Hawaii, United States,
  • United States, Illinois
    • Chicago, Illinois, United States,
  • United States, Louisiana
    • New Orleans, Louisiana, United States,
  • United States, Massachusetts
    • Boston, Massachusetts, United States,
  • United States, Michigan
    • Ann Arbor, Michigan, United States,
  • United States, New York
    • Bronx, New York, United States,
  • United States, North Carolina
    • Durham, North Carolina, United States,
  • United States, Pennsylvania
    • Philadelphia, Pennsylvania, United States,
  • United States, Texas
    • Dallas, Texas, United States,
  • Algeria,
    • Multiple Locations, , Algeria,
  • Argentina,
    • Multiple Locations, , Argentina,
  • Brazil,
    • Multiple Locations, , Brazil,
  • Egypt,
    • Multiple Locations, , Egypt,
  • France,
    • Multiple Locations, , France,
  • Germany,
    • Multiple Locations, , Germany,
  • Greece,
    • Multiple Locations, , Greece,
  • India,
    • Multiple Locations, , India,
  • Israel,
    • Multiple Locations, , Israel,
  • Japan,
    • Multiple Locations, , Japan,
  • Lebanon,
    • Multiple Locations, , Lebanon,
  • Mexico,
    • Multiple Locations, , Mexico,
  • Netherlands,
    • Multiple Locations, , Netherlands,
  • Philippines,
    • Multiple Locations, , Philippines,
  • Russian Federation,
    • Multiple Locations, , Russian Federation,
  • Saudi Arabia,
    • Multiple Locations, , Saudi Arabia,
  • Spain,
    • Multiple Locations, , Spain,
  • Taiwan,
    • Multiple Locations, , Taiwan,
  • Turkey,
    • Multiple Locations, , Turkey,
  • United Arab Emirates,
    • Multiple Locations, , United Arab Emirates,

Sponsors and Collaborators

Bayer

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02303444
Other Study ID Numbers: NX1401
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Bayer:

Progressive radioactive iodine refractory differentiated thyroid carcinoma

Additional relevant MeSH terms:

Thyroid Diseases

Thyroid Neoplasms

Sorafenib

Iodine

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019