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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

Must not have

Presence of a non-healing wound, non-healing ulcer, or bone fracture

Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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.

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My high blood pressure is not controlled even with medication.

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I have serious heart problems, such as severe heart failure or recent heart attack.

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I have fluid in my chest or abdomen causing significant breathing problems.

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I am not pregnant or breastfeeding.

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I have not had severe bleeding in the last 4 weeks.

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I have HIV or hepatitis B/C that needs antiviral treatment.

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I have a history of bleeding disorders.

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I have a condition that affects how my body absorbs nutrients.

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I currently have symptoms of interstitial lung disease.

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I do not have a serious ongoing infection.

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I have symptoms from cancer that has spread to my brain or its coverings.

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I am on medication for seizures.

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I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

progression free survival

Secondary study objectives

disease control rate

duration of stable disease

overall survival

+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

Headache

Abdominal distension

Insomnia

Arthralgia

Asthenia

Pain in extremity

Alopecia

Urine ketone body present

Blood alkaline phosphatase increased

Pulmonary embolism

Lymphopenia

Leukopenia

Blood bilirubin increased

Dyspepsia

Sepsis

Palmar-plantar erythrodysaesthesia syndrome

Hypertension

Urine leukocyte esterase positive

Abdominal pain upper

Gastrooesophageal reflux disease

Proteinuria

Rash

Flatulence

Chills

Dry mouth

Myalgia

Epistaxis

Muscle spasms

Pneumonia

pelvic fracture

Haematemesis

Disease progression

Pleural effusion

Confusional state

Mental status changes

malignant neoplasm progression

Large intestine perforation

Oesophagitis

Lung abscess

embolism

pancreatic carcinoma

fall

Death

Haemorrhage intranial

Atrial fibrillation

Colitis

Enterocutaneous fistula

Gastrointestinal haemorrhage

Upper gastrointestinal haemorrhage

Chest pain

somnolence

syncope

Febrile neutropenia

Acute kidney injury

Acute respiratory failure

Hypoxia

Pneumonia aspiration

Clostridium difficile colitis

Influenza

Perirectal abscess

Salmonella sepsis

Septic shock

hip fracture

deep vein thrombosis

haematoma

pelvic venous thrombosis

Cholangitis

Ischaemic cerebral infarction

Hyperglycaemia

subdural haematoma

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1600

0 / 22Eligibility criteria met