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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2023
• Main ID: NCT02303444
• Date of registration: 25/11/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors RIFTOS MKI
• Scientific title: RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
• Date of first enrolment: April 8, 2015
• Target sample size: 667
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02303444
• Study type: Observational

Countries of recruitment

Algeria, Argentina, Austria, Brazil, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Israel, Japan, Lebanon, Mexico, Netherlands, Norway, Philippines, Russian Federation, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thyroid Neoplasms

Intervention(s)

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Other Multikinase inhibitors

Primary Outcome(s)

Time to symptomatic progression (TTSP) from study entry [Time Frame: Up to 6 years]

Secondary Outcome(s)

PFS from initiation of first MKI [Time Frame: Up to 6 years]

Overall survival (OS) from time of study entry [Time Frame: Up to 6 years]

OS from initiation of sorafenib [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 any systemic treatment regimen [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]

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]

OS from initiation of the first Multikinase Inhibitor (MKI) [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]

Secondary ID(s)

NX1401

17852

Source(s) of Monetary Support

Please refer to primary and secondary sponsors