Trial Condition(s):
Thyroid Neoplasms
An Observational Study in differentiated thyroid cancer which is radioactive iodine (RAI) refractory to assess the use of Multikinase inhibitors (RIFTOS MKI)
Bayer Identifier:
17852
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, France | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Spain | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Netherlands | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Argentina | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Turkey | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Greece | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Brazil | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Russia | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, India | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Algeria | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Egypt | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Lebanon | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Mexico | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Philadelphia, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many locations, Philippines | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ann Arbor, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Washington, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Boston, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bronx, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Atlanta, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Birmingham, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Torrance, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Chicago, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Durham, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Dallas, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site New Orleans, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Aurora, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Los Angeles, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Plantation, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Honolulu, United States | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
2
Primary Outcome
- Time to symptomatic progression (TTSP) from study entryTTSP 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.Timeframe: Up to 6 years
Secondary Outcome
- Overall survival (OS) from time of study entryDefined 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.Timeframe: Up to 6 years
- Progression free survival (PFS) from time of study entryDefined 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.Timeframe: Up to 6 years
- OS from time of being diagnosed as radioactive iodine (RAI) refractoryDefined 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.Timeframe: Up to 6 years
- Post-progression survival (PPS) from time of symptomatic progressionDefined 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.Timeframe: Up to 6 years
- 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.Timeframe: Up to 6 years
- PFS from initiation of first MKIDefined 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.Timeframe: Up to 6 years
- OS from initiation of any systemic treatment regimenDefined 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.Timeframe: Up to 6 years
- PFS from initiation of any systemic treatment regimenDefined 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.Timeframe: Up to 6 years
- Duration of each systemic treatment regimenDefined 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.Timeframe: Up to 6 years
- 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.Timeframe: Up to 6 years
- OS from initiation of sorafenibDefined 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.Timeframe: Up to 6 years
- PFS from initiation of sorafenibDefined 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.Timeframe: Up to 6 years
- Daily dose of sorafenib per patient throughout the treatment periodTimeframe: Up to 6 years
- Number of adverse events during treatment with sorafenibTimeframe: Up to 6 years
Additional Information
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