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Kinase Inhibitor
Regorafenib for Colorectal Cancer
Phase 2
Waitlist Available
Led By Andrea Cercek, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must be able to swallow and retain oral medication
Histologically proven colorectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effects of regorafenib versus standard chemotherapy in patients with stomach cancer.
Who is the study for?
This trial is for adults over 18 with newly diagnosed metastatic colorectal adenocarcinoma who haven't been treated or have progressed after first-line therapy. They must have good organ function, a life expectancy of at least 3 months, and be able to take oral meds. Women must not be pregnant and all participants should agree to use contraception.Check my eligibility
What is being tested?
The study tests the effects of Regorafenib compared to standard chemotherapy in treating metastatic colorectal cancer. It aims to determine if Regorafenib offers better, worse, or similar outcomes as standard treatments.See study design
What are the potential side effects?
Regorafenib may cause high blood pressure, bleeding issues, liver problems like hepatitis B/C infections that need treatment, heart complications such as congestive heart failure or coronary artery disease, severe infections or bleeding events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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My diagnosis is colorectal cancer confirmed by tissue analysis.
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My cancer has spread and cannot be surgically removed, with small or limited large tumors.
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I am fully active or can carry out light work.
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My blood and liver tests are within safe ranges.
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I am 18 years old or older.
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I have not received a blood transfusion to meet the study requirements.
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I have colorectal cancer that hasn't been treated for spreading, or it got worse after my first treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression free survival
Secondary outcome measures
disease control rate
duration of stable disease
overall survival
+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
1Treatment groups
Experimental Treatment
Group I: RegorafenibExperimental Treatment1 Intervention
This is an open-label, phase II study of regorafenib for patients with metastatic colorectal carcinoma. The treatment will be repeated every week for three weeks on and one week off. Patients will be evaluated for response after every 2 cycles (8 weeks).
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?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,609 Total Patients Enrolled
Queens Cancer Center of Queens HospitalOTHER
8 Previous Clinical Trials
1,126 Total Patients Enrolled
State University of New York - Downstate Medical CenterOTHER
65 Previous Clinical Trials
12,540 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow and keep down pills.I have a wound, ulcer, or bone fracture that is not healing.My diagnosis is colorectal cancer confirmed by tissue analysis.You are expected to live for at least 3 months.My high blood pressure is not controlled even with medication.I have serious heart problems, such as severe heart failure or recent heart attack.My cancer has spread and cannot be surgically removed, with small or limited large tumors.I am fully active or can carry out light work.My blood and liver tests are within safe ranges.I am 18 years old or older.I have not received a blood transfusion to meet the study requirements.I am not pregnant and have had a negative pregnancy test within the last week, or I am post-menopausal or surgically sterilized.I have no other cancers except possibly treated skin, cervical, or superficial bladder cancer, or any cancer cured over 3 years ago.I have fluid in my chest or abdomen causing significant breathing problems.I am not pregnant or breastfeeding.I have not had severe bleeding in the last 4 weeks.I have HIV or hepatitis B/C that needs antiviral treatment.I have a history of bleeding disorders.I have a condition that affects how my body absorbs nutrients.I have colorectal cancer that hasn't been treated for spreading, or it got worse after my first treatment.I agree to use birth control from the start of the study until 3 months after the last dose.I currently have symptoms of interstitial lung disease.I do not have a serious ongoing infection.I have symptoms from cancer that has spread to my brain or its coverings.I am on medication for seizures.I haven't had major surgery or a serious injury in the last 28 days.I have had an organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
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