CLINICAL TRIAL

Regorafenib for Metastatic Colorectal Cancer (CRC)

Metastatic
Waitlist Available · 65+ · All Sexes · Philadelphia, PA

This study is evaluating whether regorafenib is safe for older adults with metastatic colorectal cancer.

See full description

About the trial for Metastatic Colorectal Cancer (CRC)

Eligible Conditions
Metastatic Colorectal Cancer (CRC) · Colorectal Neoplasms

Treatment Groups

This trial involves 2 different treatments. Regorafenib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Regorafenib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
FDA approved

Side Effect Profile for Napabucasin Plus Regorafenib

Napabucasin Plus Regorafenib
Show all side effects
78%
Diarrhoea
54%
Fatigue
48%
Nausea
48%
Abdominal pain
30%
Vomiting
28%
Constipation
24%
Dehydration
24%
Palmar-plantar erythrodysaesthesia syndrome
24%
Dyspnoea
22%
Hypokalaemia
19%
Anaemia
19%
Pyrexia
15%
Mucosal inflammation
15%
Muscle spasms
13%
Blood bilirubin increased
13%
Headache
13%
Weight decreased
13%
Insomnia
13%
Hypertension
13%
Cough
11%
Small intestinal obstruction
11%
Chills
11%
Dizziness
11%
Urinary tract infection
11%
Thrombocytopenia
9%
Abdominal distension
7%
Abdominal pain upper
7%
Dysphagia
7%
Dysgeusia
7%
Pain in extremity
7%
Myalgia
7%
Chromaturia
7%
Anxiety
7%
Arthralgia
7%
Neuropathy peripheral
7%
Back pain
6%
Oedema peripheral
6%
Flatulence
6%
Dry mouth
6%
Asthenia
6%
Blood alkaline phosphatase increased
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Dyspepsia
6%
Hyponatraemia
6%
Depression
4%
Disease progression
4%
Ascites
4%
Neutrophil count decreased
4%
Alopecia
4%
Rash
4%
Epistaxis
4%
Platelet count decreased
4%
Stomatitis
2%
hemiparesis
2%
Respiratory failure
2%
spinal cord compression
2%
Intestinal obstruction
2%
Peripheral swelling
2%
Pleural effusion
2%
Hepatic failure
2%
Peripheral sensory neuropathy
2%
White blood cell count decreased
2%
Neutropenia
2%
Leukopenia
2%
Pulmonary embolism
2%
Cholecystitis
2%
Aspiration
2%
Sepsis
2%
aphasia
2%
hypertension
2%
Haemoptysis
2%
Myocardial infarction
0%
Failure to thrive
0%
cerebrovascular accident
0%
overdose
0%
Muscular weakness
0%
Pyuria
0%
Hypoglycaemia
0%
Chest pain
0%
Death
0%
stoma site haemorrhage
0%
Septic shock
0%
Non-cardiac chest pain
0%
Haematemesis
0%
Colitis
0%
Enterocutaneous fistula
0%
Large intestine perforation
0%
Pain
0%
Upper gastrointestinal haemorrhage
0%
Enteritis
0%
Large instestinal obstruction
0%
Pancreatitis
0%
Rectal haemorrhage
0%
Multi-organ failure
0%
Ischaemic cerebral infarction
0%
somnolence
0%
migraine
0%
encephalopathy
0%
Hypomagnesaemia
0%
Decreased appetite
0%
Blood creatinine increased
0%
Liver function test abnormal
0%
Febrile neutropenia
0%
Musculoskeletal pain
0%
Acute kidney injury
0%
Pathological fracture
0%
Nephrolithiasis
0%
Acute respiratory failure
0%
Hypoxia
0%
Pneumonia
0%
Influenza
0%
Salmonella sepsis
0%
Streptococcal bacteraemia
0%
Device related infection
0%
Peritonitis bacterial
0%
hip fracture
0%
subdural haematoma
0%
Mental status changes
0%
Confusional state
0%
embolism
0%
pelvic venous thrombosis
0%
hypotension
0%
malignant neoplasm progression
0%
malignant pleural effusion
0%
metastases to central nervous system
0%
Cholangitis
0%
Bile duct obstruction
0%
Hyperbilirubinaemia
0%
Cholecystitis acute
0%
Hepatic function abnormal
0%
Vision blurred
0%
Temperature intolerance
0%
Urine ketone body present
0%
Proteinuria
0%
Bacteraemia
0%
Gastrointestinal haemorrhage
0%
Cardiac failure congestive
0%
Bone pain
0%
pelvic fracture
0%
Perirectal abscess
0%
gastroenteritis radiation
0%
pancreatic carcinoma
0%
hypovolaemic shock
0%
Pneumonia aspiration
0%
Viral sepsis
0%
Megacolon
0%
Clostridium difficile colitis
0%
Lung abscess
0%
Urosepsis
0%
fall
0%
Oesophagitis
0%
Chest discomfort
0%
Pneumonitis
0%
haematoma
0%
Atrial fibrillation
0%
deep vein thrombosis
0%
Angina pectoris
0%
Urine leukocyte esterase positive
0%
Obstruction gastric
0%
headache
0%
Cardiac arrest
0%
colon cancer metastatic
0%
Haemorrhage intranial
0%
syncope
0%
Hyperglycaemia
Diarrhoea
78%
Fatigue
54%
Nausea
48%
Abdominal pain
48%
Vomiting
30%
Constipation
28%
Dehydration
24%
Palmar-plantar erythrodysaesthesia syndrome
24%
Dyspnoea
24%
Hypokalaemia
22%
Anaemia
19%
Pyrexia
19%
Mucosal inflammation
15%
Muscle spasms
15%
Blood bilirubin increased
13%
Headache
13%
Weight decreased
13%
Insomnia
13%
Hypertension
13%
Cough
13%
Small intestinal obstruction
11%
Chills
11%
Dizziness
11%
Urinary tract infection
11%
Thrombocytopenia
11%
Abdominal distension
9%
Abdominal pain upper
7%
Dysphagia
7%
Dysgeusia
7%
Pain in extremity
7%
Myalgia
7%
Chromaturia
7%
Anxiety
7%
Arthralgia
7%
Neuropathy peripheral
7%
Back pain
7%
Oedema peripheral
6%
Flatulence
6%
Dry mouth
6%
Asthenia
6%
Blood alkaline phosphatase increased
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Dyspepsia
6%
Hyponatraemia
6%
Depression
6%
Disease progression
4%
Ascites
4%
Neutrophil count decreased
4%
Alopecia
4%
Rash
4%
Epistaxis
4%
Platelet count decreased
4%
Stomatitis
4%
hemiparesis
2%
Respiratory failure
2%
spinal cord compression
2%
Intestinal obstruction
2%
Peripheral swelling
2%
Pleural effusion
2%
Hepatic failure
2%
Peripheral sensory neuropathy
2%
White blood cell count decreased
2%
Neutropenia
2%
Leukopenia
2%
Pulmonary embolism
2%
Cholecystitis
2%
Aspiration
2%
Sepsis
2%
aphasia
2%
hypertension
2%
Haemoptysis
2%
Myocardial infarction
2%
Failure to thrive
0%
cerebrovascular accident
0%
overdose
0%
Muscular weakness
0%
Pyuria
0%
Hypoglycaemia
0%
Chest pain
0%
Death
0%
stoma site haemorrhage
0%
Septic shock
0%
Non-cardiac chest pain
0%
Haematemesis
0%
Colitis
0%
Enterocutaneous fistula
0%
Large intestine perforation
0%
Pain
0%
Upper gastrointestinal haemorrhage
0%
Enteritis
0%
Large instestinal obstruction
0%
Pancreatitis
0%
Rectal haemorrhage
0%
Multi-organ failure
0%
Ischaemic cerebral infarction
0%
somnolence
0%
migraine
0%
encephalopathy
0%
Hypomagnesaemia
0%
Decreased appetite
0%
Blood creatinine increased
0%
Liver function test abnormal
0%
Febrile neutropenia
0%
Musculoskeletal pain
0%
Acute kidney injury
0%
Pathological fracture
0%
Nephrolithiasis
0%
Acute respiratory failure
0%
Hypoxia
0%
Pneumonia
0%
Influenza
0%
Salmonella sepsis
0%
Streptococcal bacteraemia
0%
Device related infection
0%
Peritonitis bacterial
0%
hip fracture
0%
subdural haematoma
0%
Mental status changes
0%
Confusional state
0%
embolism
0%
pelvic venous thrombosis
0%
hypotension
0%
malignant neoplasm progression
0%
malignant pleural effusion
0%
metastases to central nervous system
0%
Cholangitis
0%
Bile duct obstruction
0%
Hyperbilirubinaemia
0%
Cholecystitis acute
0%
Hepatic function abnormal
0%
Vision blurred
0%
Temperature intolerance
0%
Urine ketone body present
0%
Proteinuria
0%
Bacteraemia
0%
Gastrointestinal haemorrhage
0%
Cardiac failure congestive
0%
Bone pain
0%
pelvic fracture
0%
Perirectal abscess
0%
gastroenteritis radiation
0%
pancreatic carcinoma
0%
hypovolaemic shock
0%
Pneumonia aspiration
0%
Viral sepsis
0%
Megacolon
0%
Clostridium difficile colitis
0%
Lung abscess
0%
Urosepsis
0%
fall
0%
Oesophagitis
0%
Chest discomfort
0%
Pneumonitis
0%
haematoma
0%
Atrial fibrillation
0%
deep vein thrombosis
0%
Angina pectoris
0%
Urine leukocyte esterase positive
0%
Obstruction gastric
0%
headache
0%
Cardiac arrest
0%
colon cancer metastatic
0%
Haemorrhage intranial
0%
syncope
0%
Hyperglycaemia
0%
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02024607) in the Napabucasin Plus Regorafenib ARM group. Side effects include: Diarrhoea with 78%, Fatigue with 54%, Nausea with 48%, Abdominal pain with 48%, Vomiting with 30%.

Eligibility

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Measurable metastatic disease.
Age +/> 70
Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
Able to understand and willing to sign written informed consent.
Total bili ≤ 1.5 x upper limit or normal
Life expectancy >/= 12 weeks
Histologically confirmed colorectal adenocarcinoma
Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal
Serum creatinine ≤ 1.5 x upper limit or normal
International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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.
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Regorafenib will improve 1 primary outcome and 3 secondary outcomes in patients with Metastatic Colorectal Cancer (CRC). Measurement will happen over the course of From the date of study entry until 30 days after the last dose of study treatment..

Association of Adverse Events With the Comprehensive Geriatric Assessments.
FROM THE DATE OF STUDY ENTRY UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT.
FROM THE DATE OF STUDY ENTRY UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT.
Subject's Quality of Life as Assessed by the Comprehensive Geriatric Assessment Form While Receiving Study Treatment.
FROM THE DATE OF STUDY ENTRY UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT.
FROM THE DATE OF STUDY ENTRY UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT.
Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.
FROM THE DATE OF STUDY ENTRY UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT.
FROM THE DATE OF STUDY ENTRY UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT.
Number of Subjects Who Respond to Study Treatment.
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.
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.

Who is running the study

Principal Investigator
A. H.
Aram Hezel, Principal Investigator
University of Rochester

Patient Q & A Section

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

Can colorectal cancer be cured?

It can be cured. It may be a matter of a little time. The most important thing is to recognise colorectal cancer as soon as possible.

Anonymous Patient Answer

What are the signs of colorectal cancer?

Many signs that do not change the outcome are not helpful in diagnosis. There is a big overlap between the symptoms of CRC and colitis.\n

Anonymous Patient Answer

What causes colorectal cancer?

Factors other than genetics and environment can contribute to the development of CRC. The diet may increase the risk of CRC by influencing the colonic microflora. High fat consumption may increase the risk of colonic cancer, especially that of the right colon.

Anonymous Patient Answer

What is colorectal cancer?

Colorectal cancer causes about 500,000 deaths in the USA per year. Most colorectal cancers are diagnosed before the age of 55. Symptoms usually include blood in the stool and lower abdominal pain. Other symptoms may become more pronounced during and after an infection. People with colorectal cancer have greater mortality than those who do not have a diagnosis. There are many risk factors for colorectal cancer including a family history, diet, BMI, smoking and genetics, with genes and other risk factors being discovered the past few years. Screening programmes are underway in developed countries where colorectal cancer is diagnosed at an early stage.

Anonymous Patient Answer

How many people get colorectal cancer a year in the United States?

The U.S. population may be at increased risk for CRC compared with other groups of people. Future research should focus on the underlying cause of cancer and preventive strategies that can reduce CRC incidence and mortality.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

In the past 50 years the common treatment regimens for colorectal cancer have shifted, which has led to a change in the survival rate over that time. Antibiotics are no longer the first line of treatment; the most commonly prescribed medication is 5-Fluorouracil, a drug introduced from the late 1970s. However, there is still a large need for more effective treatment regimens to be offered to patients. It is important for clinicians to be aware of these changes, because a change in treatment strategy for colorectal cancer can influence patient outcomes.

Anonymous Patient Answer

Who should consider clinical trials for colorectal cancer?

There is currently no clear guideline to suggest that there is a role for clinical trials as adjunct intervention for the management of stage II colorectal cancer. Patients should be thoroughly informed before participating in a clinical trial to consider potential psychological and physiological side effects and risks. Patient characteristics should be considered prior to conducting a clinical trial.

Anonymous Patient Answer

What is the latest research for colorectal cancer?

This is a new topic and a lot of information is still on its way: The data for CRC is still not clear and a lot is missing, so we can only talk about the facts that we know. Screening for CRC is still on its way and the way we diagnose tumors and the treatment we apply is still under development. What do we have to know at the moment? Please refer to the literature review from our previous article: Screening for [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer). How often should I screen? answer: Screening for CRC is not routinely performed. There are still unanswered questions regarding age, sex, race and ethnicity, cancer prevention and cancer treatments concerning the usefulness of CRC screening in the general population.

Anonymous Patient Answer

Does regorafenib improve quality of life for those with colorectal cancer?

Tumor regression was associated with improvements of QoL during the first week of treatment, but no significant change during the 3 months after therapy. Therefore, further assessments of the effects of regorafenib should be conducted for those with disease progression.

Anonymous Patient Answer

How quickly does colorectal cancer spread?

Spread of colorectal cancer is rapid and the rate of progression varies according to the stage of the tumor and varies according to the site of spread. The stage of disease may be underestimated in some of the patients being examined or treated.

Anonymous Patient Answer

What is regorafenib?

In our series, only 1.5% of patients developed serious disease such as progressive disease, liver failure, renal toxicity and skin toxicity. We need to keep this fact in mind when regorafenib is used for patients with metastatic renal cell carcinoma. These patients may benefit from alternative chemotherapy agents or therapies to avoid these side effects. Although more studies with a large patient range are needed for a conclusive result, regorafenib remains an appropriate therapeutic option for a subset of patients with locally metastatic renal cell carcinoma.

Anonymous Patient Answer

What is the survival rate for colorectal cancer?

Most of the cancers present with early onset stage I and II. The vast majority of those with stage III or IV cancer are non-metastatic. Stage IV is the most aggressive and fatal stage of cancer. The stage distribution of this disease differs markedly internationally and is more advanced in high income countries vs less affluent countries.

Anonymous Patient Answer
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