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Kinase Inhibitor

A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (INTEGRATEIIa Trial)

Phase 3
Waitlist Available
Research Sponsored by Australasian Gastro-Intestinal Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months following close of recruitment.
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether a new drug called regorafenib can help people with a certain type of cancer live longer. Half of the people in the trial will get regorafenib, and the other half will get a placebo (a fake treatment). Neither the patients nor the doctors will know who is getting which treatment.

Eligible Conditions
  • Esophageal cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months following close of recruitment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months following close of recruitment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Evaluation of health states experienced by participants
Objective Tumour Response Rate
Progression Free Survival
+1 more
Other study objectives
Evaluation of regorafenib Maximum Plasma Concentration [Cmax] between Asia and Rest of World cohorts.
Identification of tumour markers to that predict treatment outcomes for AGOC

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607
82%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
Large intestine perforation
1%
Oesophagitis
1%
pancreatic carcinoma
1%
Lung abscess
1%
embolism
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RegorafenibExperimental Treatment1 Intervention
Regorafenib 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
Group II: PlaceboPlacebo Group1 Intervention
Placebo 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1600

Find a Location

Who is running the clinical trial?

National Health and Medical Research Council, AustraliaOTHER
166 Previous Clinical Trials
476,456 Total Patients Enrolled
Australasian Gastro-Intestinal Trials GroupLead Sponsor
25 Previous Clinical Trials
7,713 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
69,617 Total Patients Enrolled
Academic and Community Cancer Research UnitedOTHER
53 Previous Clinical Trials
4,691 Total Patients Enrolled
Nick Pavlakis, ProfStudy ChairAGITG
1 Previous Clinical Trials
450 Total Patients Enrolled
~27 spots leftby Jan 2026
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