Submitted by: Maylyn H. Garcia 2015-06-15 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-06-18 09:59:11 Export to PDF

An Observational Study in differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to assess the use of Multikinase Inhibitors (RIFTOS MKI)

PHRR180618-001031

NCT02303444

Unspecified

RIFTOS MKI - Radioactive Iodine reFractory Asymptomatic Patients in Differentiated Thyroid Cancer - an Observational Study to Assess the Use of Multikinase Inhibitors

The study will 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.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-04-30 44 2018-12-30 2018-12-31

Ongoing

Institution Classification Region LTO #
Bayer Philippines, Inc. Private Business NCR CDRR-NCR-S-27
Institution Amount Region
Bayer Healthcare AG N/A Germany
Name E-Mail Phone Number Postal Address
Mark de Guzman mark.deguzman@bayer.com (+63 2) 548-5800 Bayer Philippines, Inc. 29th Floor, Menarco Tower, 32nd Ave., BGC, Taguig City
Name E-Mail Phone Number Postal Address
Mark De Guzman mark.deguzman@bayer.com (+63 2) 548-5800 Bayer Philippines, Inc. 29th Floor, Menarco Tower, 32nd Ave., BGC, Taguig City
Name Expertise Affiliation
Michael Lim Villa, MD Diabetes St. Luke's Medical Center - Global City
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Global City N/A

Thyroid Neoplasms

  • Time to symptomatic progression (TTSP) from study entry [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.

  • Overall survival (OS) from time of study entry [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • Progression free survival (PFS) from time of study entry [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • OS from time of being diagnosed as radioactive iodine (RAI) refractory [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • Post-progression survival (PPS) from time of symptomatic progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • OS from initiation of the first Multikinase Inhibitor (MKI) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • PFS from initiation of first MKI [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • OS from initiation of any systemic treatment regimen [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • PFS from initiation of any systemic treatment regimen [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • Duration of each systemic treatment regimen [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • 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 4 years ] [ Designated as safety issue: No ]
    In case of "Clinical Progression" the CRF will ask for the presence of specific symptoms.
  • OS from initiation of sorafenib [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • PFS from initiation of sorafenib [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
  • Daily dose of sorafenib per patient throughout the treatment period [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Number of adverse events during treatment with sorafenib [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

Recruiting

  • Algeria
  • Argentina
  • Brazil
  • Denmark
  • Egypt
  • France
  • Greece
  • India
  • Indonesia
  • Israel
  • Japan
  • Lebanon
  • Mexico
  • Netherlands
  • Norway
  • Philippines
  • Russia
  • Saudi Arabia
  • Spain
  • Sweden
  • Taiwan
  • Turkey
  • United Arab Emirates

Clinical Trial

Unspecified

2015-04-29

None

Inclusion Criteria:

  • Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma)
  • DTC refractory to RAI
  • Progression according to 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

Observational

Unspecified

Unspecified

Non-randomized

Open Label

Unspecified

Parallel

The purpose of the study is 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.

Phase IV

10

Unspecified

Unspecified

30 Apr 2015

Utilization Utilization Info
No records found.

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