check_circleStudy Completed
Thyroid Neoplasms
Bayer Identifier:
17852
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
667Trial Dates
April 2015 - July 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Many locations, Sweden | |
Withdrawn | Many locations, Denmark | |
Withdrawn | Many locations, Norway | |
Withdrawn | Many locations, Israel | |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Withdrawn | Many locations, Austria | |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Withdrawn | Many locations, United Arab Emirates | |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Withdrawn | Many locations, Indonesia | |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Withdrawn | Stony Brook, United States | |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Withdrawn | Charleston, United States | |
Withdrawn | Detroit, United States | |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 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety 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”In case of “Clinical Progression” the CRF will ask for the presence of specific symptoms.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- Daily dose of sorafenib per patient throughout the treatment perioddate_rangeTime Frame:Up to 6 yearsenhanced_encryptionNoSafety Issue:
- Number of adverse events during treatment with sorafenibdate_rangeTime Frame:Up to 6 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A