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

Bayer

Status: Completed

Conditions: Thyroid Neoplasms

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Other Multikinase inhibitors

Study type: Observational

Funder types: Industry

Identifiers

NCT02303444

17852

NX1401 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 667 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

667 participants in 2 patient groups

MKI patients

Description:

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.

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Other Multikinase inhibitors

non-MKI patients

Description:

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.

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Drug: Other Multikinase inhibitors