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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02303444
• Collaborator: (none)
• Enrollment: 667
• Locations: 34
• Actual Duration (Months): 63.5
• Patients Per Site: 19.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasms	Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Other Multikinase inhibitors

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

• Study Type: Observational
• Actual Enrollment: 667 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors
• Actual Study Start Date: Apr 8, 2015
• Actual Primary Completion Date: Jun 10, 2020
• Actual Study Completion Date: Jul 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
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); Patients can get sorafenib at any time during study.; Drug: Other Multikinase inhibitors; Patients can get MKIs at any time during study.
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); Patients can get sorafenib at any time during study.; Drug: Other Multikinase inhibitors; Patients can get MKIs at any time during study.

Outcome Measures

Primary Outcome Measures

1. Time to symptomatic progression (TTSP) from study entry [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.

Secondary Outcome Measures

1. Overall survival (OS) from time of study entry [Up to 6 years]

   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.

2. Progression free survival (PFS) from time of study entry [Up to 6 years]

   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.

3. OS from time of being diagnosed as radioactive iodine (RAI) refractory [Up to 6 years]

   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.

4. Post-progression survival (PPS) from time of symptomatic progression [Up to 6 years]

   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.

5. OS from initiation of the first Multikinase Inhibitor (MKI) [Up to 6 years]

   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.

6. PFS from initiation of first MKI [Up to 6 years]

   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.

7. OS from initiation of any systemic treatment regimen [Up to 6 years]

   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.

8. PFS from initiation of any systemic treatment regimen [Up to 6 years]

   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.

9. Duration of each systemic treatment regimen [Up to 6 years]

   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.

10. 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" [Up to 6 years]

    In case of "Clinical Progression" the CRF will ask for the presence of specific symptoms.

11. OS from initiation of sorafenib [Up to 6 years]

    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.

12. PFS from initiation of sorafenib [Up to 6 years]

    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.

13. Daily dose of sorafenib per patient throughout the treatment period [Up to 6 years]

14. Number of adverse events during treatment with sorafenib [Up to 6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Los Angeles	California	United States
3		Torrance	California	United States
4		Aurora	Colorado	United States
5		Washington	District of Columbia	United States
6		Plantation	Florida	United States
7		Atlanta	Georgia	United States
8		Honolulu	Hawaii	United States
9		Chicago	Illinois	United States
10		New Orleans	Louisiana	United States
11		Boston	Massachusetts	United States
12		Ann Arbor	Michigan	United States
13		Bronx	New York	United States
14		Durham	North Carolina	United States
15		Philadelphia	Pennsylvania	United States
16		Dallas	Texas	United States
17		Multiple Locations		Algeria
18		Multiple Locations		Argentina
19		Multiple Locations		Brazil
20		Multiple Locations		Egypt
21		Multiple Locations		France
22		Multiple Locations		Germany
23		Multiple Locations		Greece
24		Multiple Locations		India
25		Multiple Locations		Japan
26		Multiple Locations		Lebanon
27		Multiple Locations		Mexico
28		Multiple Locations		Netherlands
29		Multiple Locations		Philippines
30		Multiple Locations		Russian Federation
31		Multiple Locations		Saudi Arabia
32		Multiple Locations		Spain
33		Multiple Locations		Taiwan
34		Multiple Locations		Turkey

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02303444
• Other Study ID Numbers: 17852; NX1401
• First Posted: Dec 1, 2014
• Last Update Posted: Jun 9, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bayer: Progressive radioactive iodine refractory differentiated thyroid carcinoma
• Additional relevant MeSH terms: Thyroid Neoplasms; Thyroid Diseases; Sorafenib

Study Results

No Results Posted as of Jun 9, 2021