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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
Must not have
Patients who have poor organ function as defined by one or more of the following laboratory parameters: Persistent proteinuria of NCI-CTCAE version 4.03 Grade 3 or higher, Alanine aminotransferase and aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN) if no hepatic metastases are present; > 5 × ULN if hepatic metastases are present, Total bilirubin >1.5 × ULN; and in presence of Gilbert's syndrome, total bilirubin > 3 × ULN or direct bilirubin > 1.5 × ULN, Estimated (Cockcroft-Gault formula) or measured creatinine clearance < 40 mL/min, Platelet count < 90 × 10^9/L and absolute neutrophil count (ANC) < 1.0 × 10^9/L, Hemoglobin < 9 g/dL. Transfusion and erythropoietin may be used to reach at least 9 g/dL, but must have been administered at least 2 weeks before screening, Patients who have received neutrophil growth factor support within 14 days of screening, Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4, Patients who have had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of screening. Patient has significant traumatic injury within 28 days before screening, Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 2 years before screening. (The following are exempt from the 2-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site), Patients who have a history of a seizure disorder requiring anti-seizure medication, Patients who have metastases to the brain, Patients who are unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions, Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec, Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 90 days after the last dose of study drug. Refer to Appendix G for acceptable methods of contraception, Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the treatment assignment. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false positives) may be enrolled with written consent of the investigator, after pregnancy has been ruled out. Females of non-childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test, Women who are breastfeeding, Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism, or excretion of the study drug; or impair the assessment of study results, Patients with impaired decision-making capacity
Patients who have a non-healing wound, ulcer, or bone fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a wound, ulcer, or bone fracture that is not healing.
Select...
I do not have serious heart problems or uncontrolled high blood pressure.
Select...
I have a risk of brain bleeding or had a brain bleed in the last year.
Select...
I have been treated with sunitinib or regorafenib before.
Select...
I have been treated with more than 2 different TKI medications.
Select...
My cancer is not caused by a KIT gene mutation.
Select...
I have not had severe bleeding in the last 4 weeks.
Select...
I haven't had a stroke, mini-stroke, or blood clots in my lungs or legs in the past 6 months.
Select...
I haven't had cancer treatment or major organ radiation in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Achieving Overall Response
Secondary study objectives
Incidence of Treatment-Related Toxicity and Adverse Events
Number of Participants Achieving Clinical Benefit
Overall Survival (OS)
+1 more

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%
Lung abscess
1%
embolism
1%
pancreatic carcinoma
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
~1600
Sunitinib
2014
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
935 Previous Clinical Trials
422,169 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

Regorafenib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05366816 — Phase 2
Gastrointestinal Stromal Tumors Research Study Groups: Group A: KIT Exon 13 receiving Sunitinib, Group B: KIT Exon 17 receiving Regorafenib
Gastrointestinal Stromal Tumors Clinical Trial 2023: Regorafenib Highlights & Side Effects. Trial Name: NCT05366816 — Phase 2
Regorafenib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366816 — Phase 2
~32 spots leftby Dec 2026
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