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| ID | Type | Description | Link |
|---|---|---|---|
| NX1401 | Other Identifier | Company internal |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Patients can get sorafenib at any time during study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Progression free survival (PFS) from time of study entry |
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Inclusion Criteria:
Exclusion Criteria:
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Any setting that provides treatment for progressive asymptomatic RAI refractory DTC
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38096102 | Derived | Gianoukakis AG, Choe JH, Bowles DW, Brose MS, Wirth LJ, Owonikoko T, Babajanyan S, Worden FP. Real-world practice patterns and outcomes for RAI-refractory differentiated thyroid cancer. Eur Thyroid J. 2024 Jan 24;13(1):e230039. doi: 10.1530/ETJ-23-0039. Print 2024 Feb 1. | |
| 35950621 | Derived | Brose MS, Smit JWA, Lin CC, Tori M, Bowles DW, Worden F, Shen DH, Huang SM, Tsai HJ, Alevizaki M, Peeters RP, Takahashi S, Rumyantsev P, Guan R, Babajanyan S, Ozgurdal K, Sugitani I, Pitoia F, Lamartina L. Multikinase Inhibitors for the Treatment of Asymptomatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Global Noninterventional Study (RIFTOS MKI). Thyroid. 2022 Sep;32(9):1059-1068. doi: 10.1089/thy.2022.0061. |
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| Other Multikinase inhibitors | Drug | Patients can get MKIs at any time during study. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Daily dose of sorafenib per patient throughout the treatment period | Up to 6 years |
| Number of adverse events during treatment with sorafenib | Up to 6 years |
| Los Angeles |
| California |
| United States |
| Torrance | California | United States |
| Aurora | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Plantation | Florida | United States |
| Atlanta | Georgia | United States |
| Honolulu | Hawaii | United States |
| Chicago | Illinois | United States |
| New Orleans | Louisiana | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| The Bronx | New York | United States |
| Durham | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Dallas | Texas | United States |
| Multiple Locations | Algeria |
| Multiple Locations | Argentina |
| Multiple Locations | Brazil |
| Multiple Locations | Egypt |
| Multiple Locations | France |
| Multiple Locations | Germany |
| Multiple Locations | Greece |
| Multiple Locations | India |
| Multiple Locations | Japan |
| Multiple Locations | Lebanon |
| Multiple Locations | Mexico |
| Multiple Locations | Netherlands |
| Multiple Locations | Philippines |
| Multiple Locations | Russia |
| Multiple Locations | Saudi Arabia |
| Multiple Locations | Spain |
| Multiple Locations | Taiwan |
| Multiple Locations | Turkey (Türkiye) |
| 33537956 | Derived | Porcelli T, Luongo C, Sessa F, Klain M, Masone S, Troncone G, Bellevicine C, Schlumberger M, Salvatore D. Long-term management of lenvatinib-treated thyroid cancer patients: a real-life experience at a single institution. Endocrine. 2021 Aug;73(2):358-366. doi: 10.1007/s12020-021-02634-z. Epub 2021 Feb 3. |
| 28270435 | Derived | Brose MS, Smit J, Lin CC, Pitoia F, Fellous M, DeSanctis Y, Schlumberger M, Tori M, Sugitani I. Timing of multikinase inhibitor initiation in differentiated thyroid cancer. Endocr Relat Cancer. 2017 May;24(5):237-242. doi: 10.1530/ERC-17-0016. Epub 2017 Mar 7. |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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