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Kinase Inhibitor

Regorafenib for Colorectal Cancer

Phase 2
Waitlist Available
Led By Aram Hezel, M.D.
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
Awards & highlights

Study Summary

This trial is testing a cancer drug to see how well it works and if it has any severe side effects in older adults with metastatic colorectal cancer.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.
Secondary outcome measures
Association of Adverse Events With the Comprehensive Geriatric Assessments.
Number of Subjects Who Respond to Study Treatment.
Subject's Quality of Life as Assessed by the Comprehensive Geriatric Assessment Form While Receiving Study Treatment.

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%
Large intestine perforation
1%
Oesophagitis
1%
pancreatic carcinoma
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
120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.
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?

BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,750 Total Patients Enrolled
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,223 Total Patients Enrolled
Aram Hezel, M.D.Principal InvestigatorUniversity of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BMC CancerJournal
Retrospective Study of RAS/PIK3CA/BRAF Tumor Mutations as Predictors of Response to First-line Chemotherapy with Bevacizumab in Metastatic Colorectal Cancer Patients
Nakayama, Izuma, Eiji Shinozaki, Tomohiro Matsushima, Takeru Wakatsuki, Mariko Ogura, Takashi Ichimura, Masato Ozaka, et al.. 2017. “Retrospective Study of RAS/PIK3CA/BRAF Tumor Mutations as Predictors of Response to First-line Chemotherapy with Bevacizumab in Metastatic Colorectal Cancer Patients”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-016-2994-6.
clinicaltrials.govStudy
Regorafenib in Metastatic Colorectal Cancer
Aram Hezel 2015. "Regorafenib in Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02466009.
~3 spots leftby Apr 2025
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