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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not pregnant, nursing, or if capable of childbearing, I am using effective contraception.
Select...
I have had at least 2 treatments for my colorectal cancer and either did not respond well or cannot tolerate more.
Select...
My disease is advanced and cannot be cured with treatment.
Select...
My colorectal cancer diagnosis was confirmed through lab tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 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
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,702 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,567 Total Patients Enrolled
Kanwal RaghavPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
252 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and sign the consent form.I have not had serious heart issues like severe heart failure or a recent heart attack.I am not pregnant, nursing, or if capable of childbearing, I am using effective contraception.I do not have a serious ongoing infection.I have brain or meningeal tumors but have been stable for over 3 months after treatment.I have had at least 2 treatments for my colorectal cancer and either did not respond well or cannot tolerate more.My disease is advanced and cannot be cured with treatment.I cannot swallow pills.My colorectal cancer diagnosis was confirmed through lab tests.My doctor has approved me for regorafenib or TAS-102 treatment.I am not pregnant and agree to use birth control during the study.I can take regorafenib even if I've had TAS-102 before.I am willing to go back to the study center for follow-ups as required.I need dialysis for my kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (SOC)
- Group 2: Arm I (ctDNA testing, regorafenib, TAS-102)
Awards:
This trial has 2 awards, including:- 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.
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.
Could you shed some light on the potential risks of taking Regorafenib?
"Regorafenib's safety has been evaluated, therefore receiving a rating of 2. This is because the Phase 2 trial only has limited data to support its effectiveness and safety."
Answered by AI
What objectives are the researchers attempting to achieve through this investigation?
"This clinical trial will track the primary outcome of Treatment-related adverse events (TRAEs) over a 4 month post treatment period. Secondary outcomes, such as Hospitalizations/emergency room visits or need for medical interventions like blood transfusions and IV hydration, Median time to PRO deterioration and Median time to performance status deterioration will also be studied in comparison between arms."
Answered by AI
What other research projects have been conducted involving Regorafenib?
"Currently, there are 96 studies exploring the efficacy of regorafenib with 8 in their concluding phase. Various sites across Lakewood, New jersey and beyond have been enlisted to undertake these experiments; 1,356 locations total."
Answered by AI
Does this clinical trial still accept patients for participation?
"The clinical trial, which was first announced on the 29th of January 2019 and recently updated in late November 2022, is actively looking for participants. Data hosted on clinicialtrials.gov corroborates this fact."
Answered by AI
Is this a cutting-edge clinical trial?
"As of now, there are 96 studies ongoing to assess the efficacy of regorafenib in 457 cities and 31 different countries. The initial research on this drug was conducted by Bayer in 2014, comprising 38 participants who completed Phase 2 approval trials. Subsequently, 340 more trials have been successfully finalized since then."
Answered by AI
How many individuals are partaking in this trial?
"Affirmative. clinicaltrials.gov attests that this trial is currently enrolling patients, with the original post being published on January 29th 2019 and a recent update having been made in November 30th 2022. A total of 100 subjects are needed to participate at 1 site."
Answered by AI
To what purposes is Regorafenib usually prescribed?
"Regorafenib is commonly administered to patients who have previously received oxaliplatin chemotherapy, anti-vegf therapies, sorafenib treatments, or are facing metastatic colorectal cancer (CRC)."
Answered by AI
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