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

NCT02303444 | Completed

• 2 other identifiers: 17852NX1401
• Study Type: observational
• Target: 667
• Locations: 19 countries
• Sites: 34

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.

Conditions

Thyroid Neoplasms

Keywords

Progressive radioactive iodine refractory differentiated thyroid carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Overall survival (OS) from time of study entry

  Up to 6 years

• Progression free survival (PFS) from time of study entry

  Up to 6 years

• OS from time of being diagnosed as radioactive iodine (RAI) refractory

  Up to 6 years

• Post-progression survival (PPS) from time of symptomatic progression

  Up to 6 years

• OS from initiation of the first Multikinase Inhibitor (MKI)

  Up to 6 years

Study Arms (2)

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.

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.

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

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Patients can get sorafenib at any time during study.

MKI patients; non-MKI patients

Other Multikinase inhibitors DRUG

Patients can get MKIs at any time during study.

MKI patients; non-MKI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any setting that provides treatment for progressive asymptomatic RAI refractory DTC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (34)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Plantation, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Multiple Locations, Algeria

Location

Unknown Facility

Multiple Locations, Argentina

Location

Unknown Facility

Multiple Locations, Brazil

Location

Unknown Facility

Multiple Locations, Egypt

Location

Unknown Facility

Multiple Locations, France

Location

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Greece

Location

Unknown Facility

Multiple Locations, India

Location

Unknown Facility

Multiple Locations, Japan

Location

Unknown Facility

Multiple Locations, Lebanon

Location

Unknown Facility

Multiple Locations, Mexico

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

Multiple Locations, Philippines

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Saudi Arabia

Location

Unknown Facility

Multiple Locations, Spain

Location

Unknown Facility

Multiple Locations, Taiwan

Location

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 38096102 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.

  PMID: 35950621 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.

  PMID: 33537956 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.

  PMID: 28270435 DERIVED

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: April 8, 2015
• Primary Completion: June 10, 2020
• Study Completion: July 24, 2020
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

US (16); BR (1); IN (1); AL (1); DE (1); TU (1); RU (1); ES (1); AR (1); FR (1); TW (1); NL (1); GR (1); SA (1); EG (1); PH (1); LE (1); ME (1); JP (1)