NCT01933958

Brief Summary

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 4, 2013

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

7.6 years

First QC Date

August 29, 2013

Last Update Submit

March 21, 2022

Conditions

Gastrointestinal Stromal Tumors

Keywords

RegorafenibGastrointestinal stromal tumors

Outcome Measures

Primary Outcomes (3)

  • Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.

    Up to 6 months

  • Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.

    Up to 6 months

  • Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib

    up to 6 months

Secondary Outcomes (4)

  • overall survival (OS)

    Up to 3 years

  • time to treatment failure (TTF)

    Up to 3 years

  • tumour response

    Up to 3 years

  • Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.

    Up to 3 years

Study Arms (1)

Group 1

Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506)DRUG

The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are treated with Regorafenib/STIVARGA and meet the product label

You may qualify if:

  • Patients who are treated with Regorafenib/ STIVARGA and meet the product label.

You may not qualify if:

  • Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (2)

  • Komatsu Y, Muro K, Chosa M, Hirano K, Sunaya T, Ayukawa K, Hattori K, Nishida T. Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting. Front Oncol. 2024 Jun 17;14:1412144. doi: 10.3389/fonc.2024.1412144. eCollection 2024.

    PMID: 38952554DERIVED

  • Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.

    PMID: 25655899DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

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

August 29, 2013

First Posted

September 2, 2013

Study Start

September 4, 2013

Primary Completion

March 29, 2021

Study Completion

October 29, 2021

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

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

Locations

JP(1)