Trial Outcomes & Findings for Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers (NCT NCT02241720)
NCT ID: NCT02241720
Last Updated: 2018-01-11
Results Overview
Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
TERMINATED
PHASE2
5 participants
5 months - 3 months treatment and 8 weeks post end of treatment visit
2018-01-11
Participant Flow
Participant milestones
| Measure |
Regorafenib Treatment
160 mg regorafenib by mouth once daily for 3 weeks of every 4 week cycle
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers
Baseline characteristics by cohort
| Measure |
Regorafenib Treatment
n=5 Participants
regorafenib
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 months - 3 months treatment and 8 weeks post end of treatment visitPopulation: 3 subjects did not complete an 8 week EOT visit for: Death, Patient W/D, AE.
Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Regorafenib Treatment
n=2 Participants
regorafenib
|
|---|---|
|
Number of Participants With Stable Disease at Eight Weeks Post-Treatment
|
2 Participants
|
Adverse Events
Regorafenib Treatment
Serious adverse events
| Measure |
Regorafenib Treatment
n=5 participants at risk
regorafenib
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
heart failure
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tracheoesophageal fistula
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Regorafenib Treatment
n=5 participants at risk
regorafenib
|
|---|---|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 3
|
|
Vascular disorders
Hypertension
|
80.0%
4/5 • Number of events 4
|
|
Metabolism and nutrition disorders
deydration
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 2
|
|
Investigations
hyperbilirubinemia
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
maculopapular rash
|
20.0%
1/5 • Number of events 2
|
|
Blood and lymphatic system disorders
anemia
|
20.0%
1/5 • Number of events 1
|
|
Endocrine disorders
hypothyroidism
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
headache
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
oral pain
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
mucositis oral
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
syncope
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
hypotension
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
voice alteration
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place