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A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890731
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.

Condition or disease Intervention/treatment Phase
Solid Cancer Drug: BAY73-4506 (Regorafenib, Stivarga) Phase 2

Detailed Description:
The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis, or Has Been Stopped Prematurely.
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : November 9, 2023
Estimated Study Completion Date : November 9, 2023


Arm Intervention/treatment
Adult patients
Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.
Drug: BAY73-4506 (Regorafenib, Stivarga)
Regorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off).
Other Name: Tyrosine-kinase inhibitor




Primary Outcome Measures :
  1. Frequency of serious adverse events (SAEs) [ Time Frame: Up to 57 months ]
  2. Severity of serious adverse events (SAEs) [ Time Frame: Up to 57 months ]
    Severity is determined by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).

  3. Frequency of protocol-defined adverse events (AEs) [ Time Frame: Up to 57 months ]
    Comprise adverse events of CTCAE (version 5.0) grade 3 and 4, or adverse events of grade 2 if affecting vital organs

  4. Severity of protocol-defined adverse events (AEs) [ Time Frame: Up to 57 months ]
    Severity is determined by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).


Secondary Outcome Measures :
  1. Frequency of dose modifications [ Time Frame: Up to 57 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be age-eligible in the feeder study at the time of signing the informed consent.
  • Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
  • Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
  • Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Exclusion Criteria:

  • Medical reasons not to start the next treatment cycle in the respective feeder
  • Pregnancy

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): NCT03890731


Locations
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United States, Florida
Tampa General Medical Group
Tampa, Florida, United States, 33606
Germany
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Köln
Köln, Nordrhein-Westfalen, Germany, 50937
Italy
A.O.U. Careggi
Firenze, Toscana, Italy, 50134
Japan
Saiseikai Utsunomiya Hospital
Utsunomiya-shi, Tochigi, Japan, 321-0974
United Kingdom
Mount Vernon Hospital
Northwood, United Kingdom, HA6 2RN
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03890731    
Other Study ID Numbers: 20328
2018-003650-24 ( EudraCT Number )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bayer:
Metastatic colorectal cancer (mCRC)
Renal cell cancer
Gastro-intestinal stromal tumor
Hepatocellular carcinoma