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Tyrosine Kinase Inhibitor
Sunitinib + Regorafenib for GIST
Phase 2
Recruiting
Led By Jonathan Trent, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
Patients who have histologically confirmed metastatic or unresectable GIST. Unresectable GIST must be confirmed to be unresectable by an experienced surgeon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test if changes to the KIT gene can help predict how well a patient will respond to a standard treatment.
Who is the study for?
Adults with advanced or inoperable Gastrointestinal Stromal Tumors (GIST) who have previously been treated with imatinib but didn't respond well or couldn't tolerate it. They must be able to perform daily activities with minimal assistance (ECOG PS 0-2) and have specific mutations in the KIT gene, which will be checked through a blood test or biopsy.Check my eligibility
What is being tested?
The trial is testing whether changes in certain parts of the DNA of the KIT gene can predict how well patients respond to Sunitinib and Regorafenib, which are standard treatments for GIST. The study aims to guide therapy choices based on individual genetic profiles.See study design
What are the potential side effects?
Sunitinib and Regorafenib may cause side effects like fatigue, high blood pressure, bleeding problems, skin reactions, digestive issues such as diarrhea and liver function changes. Heart problems are also possible but less common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and up to being unable to work but can still move around.
Select...
My GIST cannot be removed by surgery as confirmed by a surgeon.
Select...
I am 18 years old or older.
Select...
My cancer has a specific mutation in the KIT gene, found through a blood test or biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Achieving Overall Response
Secondary outcome measures
Incidence of Treatment-Related Toxicity and Adverse Events
Number of Participants Achieving Clinical Benefit
Overall Survival (OS)
+1 moreSide effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT0202460782%
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B: KIT Exon 17 receiving RegorafenibExperimental Treatment2 Interventions
Participants with KIT mutation on exon 17 will receive Regorafenib. Participants showing disease progression after first-assigned Regorafenib therapy have the option to receive Sunitinib therapy. Total allotted time for treatment is up to 12 months.
Group II: Group A: KIT Exon 13 receiving SunitinibExperimental Treatment2 Interventions
Participants with KIT mutation on exon 13 will receive Sunitinib. Participants showing disease progression after first-assigned Sunitinib therapy have the option to receive Regorafenib therapy. Total allotted time for treatment is up to 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580
Sunitinib
2014
Completed Phase 3
~4380
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
900 Previous Clinical Trials
409,884 Total Patients Enrolled
Jonathan Trent, MD, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
68 Total Patients Enrolled
2 Trials studying Gastrointestinal Stromal Tumors
68 Patients Enrolled for Gastrointestinal Stromal Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a wound, ulcer, or bone fracture that is not healing.I am able to care for myself and up to being unable to work but can still move around.My GIST cannot be removed by surgery as confirmed by a surgeon.I've had imatinib or other treatments for my cancer but they didn't work or caused side effects.I do not have serious heart problems or uncontrolled high blood pressure.I have a risk of brain bleeding or had a brain bleed in the last year.I have been treated with sunitinib or regorafenib before.I have been treated with more than 2 different TKI medications.My cancer is not caused by a KIT gene mutation.I have not had severe bleeding in the last 4 weeks.I haven't had a stroke, mini-stroke, or blood clots in my lungs or legs in the past 6 months.I am 18 years old or older.I haven't had cancer treatment or major organ radiation in the last 2 weeks.My cancer has a specific mutation in the KIT gene, found through a blood test or biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: KIT Exon 13 receiving Sunitinib
- Group 2: Group B: KIT Exon 17 receiving Regorafenib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Regorafenib been granted authorization from the FDA?
"With Phase 2 trials providing evidence of safety but no efficacy, Regorafenib was rated a 2 on the Power team's scale."
Answered by AI
Are there any openings at present for participation in this trial?
"Affirmative. According to clinicaltrials.gov, this particular medical trial is actively recruiting patients and was first uploaded on January 1st of 2023 with the last update taking place on November 28th 2022. 48 participants need to be enrolled across a single site for successful completion of the study."
Answered by AI
To what extent has this clinical trial attracted participants?
"Affirmative. Clinicaltrials.gov has declared that this research project, first posted on January 1st 2023, is still seeking participants. A total of 48 individuals are needed from one medical centre for the trial to be completed successfully."
Answered by AI
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