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Stivarga Real Life Evidence in Hungary

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ClinicalTrials.gov Identifier: NCT02656524
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

Condition or disease Intervention/treatment
Colorectal Neoplasms Drug: Regorafenib (Stivarga, BAY73-4506)

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness of Stivarga (Regorafenib) for Patients With Metastatic Colorectal Cancer in the Hungarian Real World Setting
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Group/Cohort Intervention/treatment
Cohort1/Regorafenib
All patients with at least 1 treatment with regorafenib
Drug: Regorafenib (Stivarga, BAY73-4506)
Product is used in accordance with SmPC




Primary Outcome Measures :
  1. Length of treatment for each treatment episode [ Time Frame: Retrospective analysis of 2 year period ]
    The length of each treatment episode will be calculated based on the duration between the initiation date of a treatment episode and the end date of the same treatment episode

  2. Progression Free Survival (PFS) [ Time Frame: Retrospective analysis of 2 year period ]
    PFS will be defined as days between start of the therapy and the date of the medical doctors opinion about progression (confirmed by radiology or clinical assessment)

  3. Overall Survival (OS) [ Time Frame: Retrospective analysis of 2 year period ]
  4. Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Retrospective analysis of 2 year period ]

Secondary Outcome Measures :
  1. Resource utilization per patient [ Time Frame: Retrospective analysis of 2 year period ]
    Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing


Other Outcome Measures:
  1. Time to treatment failure (TTF) [ Time Frame: Retrospective analysis of 2 year period ]
    Time to treatment failure is defined as days between the first drug delivery to the health care provider and date of treatment discontinuation due to any reason, including death

  2. Time to progression (TTP) [ Time Frame: Retrospective analysis of 2 year period ]
    Time to progression is defined as days between the first drug delivery to the health care provider and the date of progression defined by the medical doctor

  3. Characteristics of patients with better response [ Time Frame: Retropsective analysis of 2 year period ]
    Patients with "better response" are defined as receiving more cycles of regorafenib treatment than the median number of cycles (2 cycles). Their distribution is analyzed by KRAS status, by the location of the primary tumour, by age, by prior cancer therapies and by location of metastases.

  4. Time frame between the baseline computed tomography and the first drug delivery [ Time Frame: Retrospective analysis of 2 year period ]
    Time frame between the date of the baseline computed tomography (CT) and the date of the first drug delivery to the health care provider



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be all patients who met the criteria within the SmPC. Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle.
Criteria

Inclusion Criteria:

  • Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).

Exclusion Criteria:

  • Not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656524


Locations
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Hungary
Budapest, Hungary
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02656524     History of Changes
Other Study ID Numbers: 18686
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by Bayer:
Metastatic colorectal cancer

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases