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Tyrosine Kinase Inhibitor

ctDNA Testing for Colorectal Cancer

Phase 2

Waitlist Available

Led By Kanwal Raghav

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception will be excluded.

Patients must have had at least 2 prior therapies for mCRC and have either progressed on or intolerant to these agents or use of these agents is contraindicated.

Must not have

Congestive heart failure > New York Heart Association (NYHA) class 2, unstable angina, new-onset angina or myocardial infarction less than 3 months prior to randomization.

Ongoing infection > grade 2 CTCAE version 4.0.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trialstudies how well ctDNA testing works to guide treatment for advanced colorectal cancer using regorafenib or TAS-102. Blood samples will be used to understand how well patients respond.

Who is the study for?

This trial is for adults with advanced or metastatic colorectal cancer who have tried at least two prior treatments, including specific chemotherapy drugs. They must be able to take oral medications, complete questionnaires, and provide blood samples. Pregnant women are excluded, as well as those with severe infections, recent heart issues, kidney failure requiring dialysis, or symptomatic brain tumors.

What is being tested?

The study is testing if using circulating cell-free tumor DNA (ctDNA) can guide treatment between regorafenib and TAS-102 effectively in patients whose colorectal cancer has spread. Both drugs aim to block enzymes that promote tumor cell growth.

What are the potential side effects?

Regorafenib and TAS-102 may cause fatigue, hand-foot skin reactions (redness and pain on palms or soles), diarrhea, high blood pressure, rash or other skin changes. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, nursing, or if capable of childbearing, I am using effective contraception.

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I have had at least 2 treatments for my colorectal cancer and either did not respond well or cannot tolerate more.

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My disease is advanced and cannot be cured with treatment.

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My colorectal cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had serious heart issues like severe heart failure or a recent heart attack.

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I do not have a serious ongoing infection.

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I cannot swallow pills.

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I need dialysis for my kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC)

Treatment-related adverse events (TRAEs) of interest (grade 3/4 toxicity, intolerable grade 2 toxicity, or any toxicity requiring dose reduction) between arms

Secondary study objectives

Cost measured in US dollars

Mean patient-reported outcomes (PROs) score as per MD Anderson Symptom Inventory (MDASI-GI)

Mean patient-reported outcomes (PROs) score as per PRO-CTCAE

+7 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

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (ctDNA testing, regorafenib, TAS-102)Experimental Treatment5 Interventions

Patients will receive either regorafenib by mouth on days 1-21 every 28 day cycle or TAS-102 by mouth twice daily on days 1-5 and 8-12 every 28 day cycle. Patients in this arm will get ctDNA testing and will continue treatment beyond 1st cycle depending on ctDNA results. Beyond that patients will continue treatment in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (SOC)Active Control5 Interventions

Patients will receive either regorafenib by mouth on days 1-21 every 28 day cycle or TAS-102 by mouth twice daily on days 1-5 and 8-12 every 28 day cycle as per standard of care. Patients in this arm will continue treatment in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAS-102

Not yet FDA approved

Regorafenib

FDA approved

0 / 8Eligibility criteria met