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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003650-24 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients | Other | Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY73-4506 (Regorafenib, Stivarga) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc. | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
| Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
| Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs) | A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
| Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs) | A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Modifications | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Medical Group | Tampa | Florida | 33606 | United States | ||
| Eberhard-Karls-Universität Tübingen |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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, 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.vivli.org 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 member section of the portal.
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This was a rollover study designed to enroll participants from ongoing or future feeder studies. Overall, 6 subjects were enrolled and treated in this study.
The study was conducted in multiple centers located in 5 countries (including Germany, Japan, Italy, United Kingdom, United States), first subject first visit of the study was on 02 APR 2019 and last subject last visit was on 28 FEB 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regorafenib | Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2018 | Feb 7, 2024 |
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|
|
| Tübingen |
| Baden-Wurttemberg |
| 72076 |
| Germany |
| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| A.O.U. Careggi | Florence | Tuscany | 50134 | Italy |
| Saiseikai Utsunomiya Hospital | Utsunomiya | Tochigi | 321-0974 | Japan |
| Mount Vernon Hospital | Northwood | HA6 2RN | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regorafenib | Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc. | SAF | Posted | Number | participants | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | SAF | Posted | Number | participants | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs) | A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. | SAF | Posted | Number | participants | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs) | A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | SAF | Posted | Number | participants | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose Modifications | SAF | Posted | Number | participants | from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months) |
|
|
|
from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
The study had no dosage arms/groups as it was a rollover study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regorafenib | Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment. | 0 | 6 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Electrocardiogram change | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cerebral venous sinus thrombosis | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2023 | Feb 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Worst grade - Grade 1 |
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| Worst grade - Grade 2 |
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| Worst grade - Grade 3 |
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| Worst grade - Grade 4 |
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| Worst grade - Grade 5 (death) |
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| Denominators |
|---|
| Categories |
|---|
| Any modification |
| |||||
| Interruption/Delay |
| |||||
| Drug withdrawn |
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