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

Thyroid Neoplasms Clinical Trial

— RIFTOS MKI  

Official title:

RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303444
• Other study ID #: 17852
• Secondary ID: NX1401
• Status: Completed
• Start date: April 8, 2015
• Est. completion date: July 24, 2020

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The primary objective of this study was 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: July 24, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Patients can get sorafenib at any time during study.
• Other Multikinase inhibitors
Patients can get MKIs at any time during study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Brazil,  Egypt,  France,  Germany,  Greece,  India,  Japan,  Lebanon,  Mexico,  Netherlands,  Philippines,  Russian Federation,  Saudi Arabia,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 6 years
Secondary	Daily dose of sorafenib per patient throughout the treatment period		Up to 6 years
Secondary	Number of adverse events during treatment with sorafenib		Up to 6 years

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