Trial Outcomes & Findings for A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed (NCT NCT03890731)
NCT ID: NCT03890731
Last Updated: 2024-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)
Results posted on
2024-04-02
Participant Flow
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.
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.
Participant milestones
| Measure |
Regorafenib
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Regorafenib
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Overall Study
Progressive disease
|
1
|
|
Overall Study
Patient's decision
|
1
|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed
Baseline characteristics by cohort
| Measure |
Regorafenib
n=6 Participants
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)Population: SAF
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.
Outcome measures
| Measure |
Regorafenib
n=6 Participants
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE
|
6 participants
|
|
Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
- Non-serious
|
6 participants
|
|
Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
- Serious
|
3 participants
|
PRIMARY outcome
Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)Population: SAF
AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Outcome measures
| Measure |
Regorafenib
n=6 Participants
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 1
|
0 participants
|
|
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 2
|
2 participants
|
|
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 3
|
1 participants
|
|
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 4
|
3 participants
|
|
Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 5 (death)
|
0 participants
|
PRIMARY outcome
Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)Population: SAF
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
Outcome measures
| Measure |
Regorafenib
n=6 Participants
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Any AE
|
5 participants
|
|
Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
- Non-serious
|
5 participants
|
|
Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
- Serious
|
1 participants
|
PRIMARY outcome
Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)Population: SAF
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
Outcome measures
| Measure |
Regorafenib
n=6 Participants
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 1
|
1 participants
|
|
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 2
|
3 participants
|
|
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 3
|
0 participants
|
|
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 4
|
1 participants
|
|
Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)
Worst grade - Grade 5 (death)
|
0 participants
|
SECONDARY outcome
Timeframe: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)Population: SAF
Outcome measures
| Measure |
Regorafenib
n=6 Participants
Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
|
|---|---|
|
Number of Participants With Dose Modifications
Any modification
|
6 participants
|
|
Number of Participants With Dose Modifications
Interruption/Delay
|
2 participants
|
|
Number of Participants With Dose Modifications
Drug withdrawn
|
5 participants
|
Adverse Events
Regorafenib
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regorafenib
n=6 participants at risk
Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.
|
|---|---|
|
Infections and infestations
Peritonitis
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Investigations
Electrocardiogram change
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Regorafenib
n=6 participants at risk
Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 3 • 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.
|
|
Eye disorders
Retinal vein occlusion
|
16.7%
1/6 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 3 • 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.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Infections and infestations
Lower respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • Number of events 2 • 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.
|
|
Investigations
Haemoglobin decreased
|
16.7%
1/6 • Number of events 11 • 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.
|
|
Investigations
International normalised ratio increased
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Number of events 3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
16.7%
1/6 • Number of events 3 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
16.7%
1/6 • Number of events 6 • 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.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
2/6 • Number of events 4 • 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.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 5 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60