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

Completed

• Conditions: Thyroid Neoplasms
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Other Multikinase inhibitors

• Registration Number: NCT02303444
• Lead Sponsor: Bayer

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-01
• Study Start: 2015-04-08
• Primary Completion: 2020-06-10
• Study Completion: 2020-07-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MKI patients	Sorafenib (Nexavar, BAY43-9006)	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.
MKI patients	Other Multikinase inhibitors	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.
non-MKI patients	Sorafenib (Nexavar, BAY43-9006)	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.
non-MKI patients	Other Multikinase inhibitors	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.

Primary Outcome Measures

Name	Time	Method
Time to symptomatic progression (TTSP) from study entry	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

Name	Time	Method
Overall survival (OS) from time of study entry	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.
Progression free survival (PFS) from time of study entry	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.
OS from time of being diagnosed as radioactive iodine (RAI) refractory	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.
Post-progression survival (PPS) from time of symptomatic progression	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.
PFS from initiation of first MKI	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.
OS from initiation of any systemic treatment regimen	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.
OS from initiation of sorafenib	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.
PFS from initiation of sorafenib	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.
Daily dose of sorafenib per patient throughout the treatment period	Up to 6 years
PFS from initiation of any systemic treatment regimen	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.
OS from initiation of the first Multikinase Inhibitor (MKI)	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.
Duration of each systemic treatment regimen	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.
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"	Up to 6 years	In case of "Clinical Progression" the CRF will ask for the presence of specific symptoms.
Number of adverse events during treatment with sorafenib	Up to 6 years