Thyroid NeoplasmsRIFTOS MKINCT02303444
An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors
An observational study of Thyroid Neoplasms, run by Bayer at 34 sites in 19 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006) and Other Multikinase inhibitors
- How many people
- 667 participants
- Where
- 34 sitesin 19 countries
- Study dates
- 8 Apr 2015to 24 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any setting that provides treatment for progressive asymptomatic RAI refractory DTC
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
34 sites in 19 countries.
34 sites in 19 countries
United States16 sites
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Honolulu, Hawaii
Study site
Los Angeles, California
Study site
New Orleans, Louisiana
Study site
Philadelphia, Pennsylvania
Study site
Plantation, Florida
Study site
The Bronx, New York
Study site
Torrance, California
Study site
Washington D.C., District of Columbia
About this study
Official title: RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
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.
Read the 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.
- Conditions
- Thyroid Neoplasms
- Being tested
- Sorafenib (Nexavar, BAY43-9006), Other Multikinase inhibitors
- Keywords
- Progressive radioactive iodine refractory differentiated thyroid carcinoma
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Patients can get sorafenib at any time during study.
Other Multikinase inhibitorsDrug
Patients can get MKIs at any time during study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Other Multikinase inhibitors | |
| 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. Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Other Multikinase inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 years
Secondary outcomes (14)
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.
Measured: Up to 6 years
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 years
Daily dose of sorafenib per patient throughout the treatment period
Measured: Up to 6 years
Number of adverse events during treatment with sorafenib
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study start8 Apr 2015
- Primary completion10 Jun 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303444
- Sponsor's protocol ID
- 17852
- Other IDs
- NX1401
- Acronym
- RIFTOS MKI
- Status last verified
- Jun 2023
- First submitted
- 25 Nov 2014
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38096102Brose 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.
PubMed 35950621Porcelli 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.
PubMed 33537956Brose 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.
PubMed 28270435
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
- ClinicalTrials.gov ID
- NCT02303444
- Acronym / sponsor ID
- RIFTOS MKI / 17852
- Conditions
- Thyroid Neoplasms
- Keywords
- Progressive radioactive iodine refractory differentiated thyroid carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MKI patients | – | Drug: Sorafenib (Nexavar, BAY43-9006), Drug: Other Multikinase inhibitorsAsymptomatic 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 | – | Drug: Sorafenib (Nexavar, BAY43-9006), Drug: Other Multikinase inhibitorsAsymptomatic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any setting that provides treatment for progressive asymptomatic RAI refractory DTC
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Patients can get sorafenib at any time during study. | Drug | MKI patients, non-MKI patients |
| Other Multikinase inhibitorsPatients can get MKIs at any time during study. | Drug | MKI patients, non-MKI patients |
Primary outcome
Time to symptomatic progression (TTSP) from study entry
Time frame: 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.
14 secondary outcomes
Overall survival (OS) from time of study entry
Time frame: Up to 6 years
Progression free survival (PFS) from time of study entry
Time frame: Up to 6 years
OS from time of being diagnosed as radioactive iodine (RAI) refractory
Time frame: Up to 6 years
Post-progression survival (PPS) from time of symptomatic progression
Time frame: Up to 6 years
OS from initiation of the first Multikinase Inhibitor (MKI)
Time frame: Up to 6 years
PFS from initiation of first MKI
Time frame: Up to 6 years
OS from initiation of any systemic treatment regimen
Time frame: Up to 6 years
PFS from initiation of any systemic treatment regimen
Time frame: Up to 6 years
Duration of each systemic treatment regimen
Time frame: 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"
Time frame: Up to 6 years
OS from initiation of sorafenib
Time frame: Up to 6 years
PFS from initiation of sorafenib
Time frame: Up to 6 years
Daily dose of sorafenib per patient throughout the treatment period
Time frame: Up to 6 years
Number of adverse events during treatment with sorafenib
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 38096102Gianoukakis 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.
- Derived from this study: PubMed 35950621Brose 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.
- Derived from this study: PubMed 33537956Porcelli 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.
- Derived from this study: PubMed 28270435Brose 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
34 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms, run by Bayer at 34 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Algeria, Argentina, Brazil, Egypt and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to symptomatic progression (TTSP) from study entry (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.