← Back to Search

Kinase Inhibitor

Regorafenib for Gastroesophageal 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

INTEGRATEIIa 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
  • Gastroesophageal Cancer

INTEGRATEIIa Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Evaluation of health states experienced by participants
Objective Tumour Response Rate
Progression Free Survival
+1 more
Other outcome measures
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%
Lung abscess
1%
pancreatic carcinoma
1%
Oesophagitis
1%
Large intestine perforation
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

INTEGRATEIIa 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
~1580

Find a Location

Who is running the clinical trial?

National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
474,887 Total Patients Enrolled
Australasian Gastro-Intestinal Trials GroupLead Sponsor
22 Previous Clinical Trials
7,503 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
67,203 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of patients who can join this clinical trial?

"The research team is no longer recruiting patients for this trial. The study was created on 2016-11-01 and last updated on 2022-01-11. If you are interested in other trials, there are 63 trials for Regorafenib currently enrolling patients and 288 studies actively searching for patients with gastro-oesophageal cancer."

Answered by AI

What are the unique aspects of this clinical trial?

"First studied in 2013, Regorafenib has gone through many different phases of clinical trials. After the first Phase 1 trial with 11 patients, the drug was approved for Phase 2 trials. Now, there are 63 active trials in 424 cities and 30 countries."

Answered by AI

Can you provide more information about other Regorafenib studies which have been completed?

"At the moment, there are 63 clinical trials underway that are studying the effects of Regorafenib. Of these, 8 are in Phase 3. Many of the trials are taking place in Commack, New york, but there are a total of 1,300 locations across the globe that are conducting these studies."

Answered by AI

Is there a chance that Regorafenib could cause long-term harm?

"There is prior clinical data supporting Regorafenib's safety, so it received a score of 3."

Answered by AI

How many different medical clinics are participating in this study?

"Currently, this study is taking place at Mayo Clinic Arizona in Scottsdale, Carle Cancer Center NCI Community Oncology Research Program in Urbana, USC Norris in Los Angeles, and 4 other locations."

Answered by AI

What are the most common illnesses that Regorafenib has been known to improve?

"Patients that have received anti-VEGF therapy, have active advance directives, or are currently being treated with sorafenib can be given Regorafenib."

Answered by AI

Is it possible to still sign up for this experiment?

"This particular clinical trial is no longer looking for new participants. The trial was posted on 2016-11-01 and edited for the last time on 2022-01-11. However, there are other active studies that may be of interest. For example, there are currently 63 studies investigating Regorafenib and 288 studies involving patients with gastro-oesophageal cancer."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer
2016. "A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02773524.
All > Debbies Dream > Esophageal Cancer
~30 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top