TAS-102 for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MD Anderson Cancer Center, Houston, TX
Colorectal Cancer+2 More
TAS-102 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood.

Eligible Conditions

  • Colorectal Cancer
  • Colorectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colorectal Cancer

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: up to 6 months

up to 6 months
To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Colorectal Cancer

Side Effects for

TAS-102+BSC
42%Anaemia
38%Neutropenia
37%Nausea
33%Decreased appetite
26%Fatigue
24%Vomiting
22%Diarrhoea
19%Asthenia
17%Leukopenia
15%Abdominal pain
15%Neutrophil count decreased
13%Constipation
10%Thrombocytopenia
9%Blood alkaline phosphatase increased
8%Platelet count decreased
7%White blood cell count decreased
7%Back pain
7%Abdominal pain upper
7%Pyrexia
6%Aspartate aminotransferase increased
6%Lymphopenia
6%Hypoalbuminaemia
6%Dyspnoea
6%Weight decreased
6%General physical health deterioration
5%Blood bilirubin increased
5%Alanine aminotransferase increased
5%Ascites
5%Oedema peripheral
4%Dysphagia
4%Stomatitis
4%Abdominal distension
4%Alopecia
3%Anxiety
3%Hypocalcaemia
3%Hypokalaemia
3%Pleural effusion
3%Urinary tract infection
3%Malaise
3%Insomnia
3%Hyperglycaemia
3%Cough
3%Hyperbilirubinaemia
3%Dysgeusia
3%Blood creatinine increased
2%Oral candidiasis
2%Pruritus
2%Mucosal inflammation
2%Blood urea increased
2%Dizziness
2%Paraesthesia
2%Palpitations
2%Oedema
2%Hypomagnesaemia
2%Headache
2%Pancytopenia
2%Upper respiratory tract infection
2%Arthralgia
2%Hypotension
1%Proteinuria
1%Pain in extremity
1%Acute kidney injury
1%Septic shock
1%Pain
1%Lymphocyte count decreased
1%Palmar-Plantar erythrodysaesthesia syndrome
1%Pneumonia
1%Shock haemorrhagic
1%Abdominal discomfort
1%Melaena
1%Chest pain
1%Groin pain
1%Peripheral sensory neuropathy
1%Myalgia
1%Hiccups
1%Nail disorder
1%Cancer pain
1%Confusional state
1%Dysuria
1%Delirium
1%Epistaxis
1%Haematemesis
1%Chest discomfort
1%Fall
1%Protein total decreased
1%Spinal pain
1%Failure to thrive
1%Ileus
1%Febrile neutropenia
1%Choluria
1%Dry mouth
1%Myocardial infarction
1%Vertigo
1%Metastases to central nervous system
1%Abdominal pain lower
1%Gastrooesophageal reflux disease
1%Haemorrhoidal haemorrhage
1%Jaundice
1%Conjunctivitis
1%Lower respiratory tract infection
1%Tonsillitis
1%Herpes zoster
1%Nasopharyngitis
1%Respiratory tract infection
1%Haemoglobin decreased
1%Red blood cell count decreased
1%Enzyme level increased
1%Agitation
1%Urinary retention
1%Pneumonia aspiration
1%Pulmonary embolism
1%Depression
1%Deep vein thrombosis
1%Productive cough
1%Tachycardia
1%Bronchitis
1%Rhinitis
1%Gamma-Glutamyltransferase increased
1%Cachexia
1%Muscle atrophy
1%Musculoskeletal pain
1%Dysphonia
1%Gastric haemorrhage
1%Gastrointestinal haemorrhage
1%Acute coronary syndrome
1%Hepatic failure
1%Upper gastrointestinal haemorrhage
1%Oesophageal pain
1%Odynophagia
1%Toothache
1%Dyspepsia
1%Flatulence
1%Rectal haemorrhage
1%Impaired gastric emptying
1%Chills
1%Liver disorder
1%Cystitis
1%Hepatic enzyme increased
1%Dehydration
1%Hyponatraemia
1%Bone pain
1%Lethargy
1%Tumour pain
1%Somnolence
1%Neuropathy peripheral
1%Dyspnoea exertional
1%Oropharyngeal pain
1%Decubitus ulcer
1%Dermatitis
1%Dry skin
1%Night sweats
1%Hypertension
1%Pallor
1%Embolism
1%Rash
1%Intestinal obstruction
1%Obstruction gastric
1%Small intestinal obstruction
1%Infection
1%Neutropenic sepsis
1%Tumour haemorrhage
0%Biliary sepsis
0%Staphylococcal infection
0%Pollakiuria
0%Renal colic
0%Limb discomfort
0%Transient ischaemic attack
0%Atrial flutter
0%Peroneal nerve palsy
0%Herpes virus infection
0%Urinary tract infection bacterial
0%Transfusion reaction
0%Blood creatinine decreased
0%Vital capacity abnormal
0%Hyperkalaemia
0%Breast pain
0%Hyperhidrosis
0%Jaundice cholestatic
0%Hepatitis toxic
0%Neoplasm malignant
0%Bilirubin conjugated increased
0%Hemiparesis
0%Joint swelling
0%Bradycardia
0%Eye irritation
0%Eye pain
0%Gastric stenosis
0%Intra-Abdominal fluid collection
0%Hypothermia
0%Hepatic pain
0%Oesophageal candidiasis
0%Hypertransaminasaemia
0%Cellulitis
0%Accidental overdose
0%Creatinine renal clearance decreased
0%International normalised ratio increased
0%Platelet count increased
0%Electrolyte imbalance
0%Hypophagia
0%Pleuritic pain
0%Upper respiratory tract inflammation
0%Petechiae
0%Cardio-Respiratory arrest
0%Sinusitis
0%Typhoid fever
0%Clostridium difficile colitis
0%Brain neoplasm
0%Malnutrition
0%Bacterial infection
0%Lower gastrointestinal haemorrhage
0%Pyuria
0%Cholangitis
0%Thoracic vertebral fracture
0%Alkalosis hypochloraemic
0%Face oedema
0%Localised oedema
0%Tracheobronchitis
0%Radiation injury
0%Neutrophil count
0%Liver function test increased
0%Bone swelling
0%Osteoporosis
0%Nervousness
0%Pleurisy
0%Clostridium difficile infection
0%Hypoglycaemia
0%Epigastric discomfort
0%Clavicle fracture
0%Neutrophilia
0%Angina pectoris
0%Altered state of consciousness
0%Cheilitis
0%Cerebral infarction
0%Ureteric cancer metastatic
0%Lymphangiosis carcinomatosa
0%Sinus tachycardia
0%Aphthous ulcer
0%Ischaemic stroke
0%Venous thrombosis
0%Anal inflammation
0%Cardiac disorder
0%Ear pain
0%Eructation
0%Visual impairment
0%Eye pruritus
0%Cardiovascular insufficiency
0%Mitral valve incompetence
0%Pericardial effusion
0%Ear discomfort
0%Anal pruritus
0%Lacrimation increased
0%Haematochezia
0%Faeces discoloured
0%Mouth haemorrhage
0%Haemorrhoids
0%Perfume sensitivity
0%Portal vein thrombosis
0%Erysipelas
0%Drug intolerance
0%Cholecystitis acute
0%Angular cheilitis
0%Biliary colic
0%Feeling hot
0%Hepatic function abnormal
0%Hepatomegaly
0%Skin infection
0%Blood bilirubin
0%Gingival abscess
0%Laryngitis
0%Aspartate aminotransferase
0%Foreign body in gastrointestinal tract
0%Procedural pain
0%Haematocrit decreased
0%Alanine aminotransferase
0%Blood alkaline phosphatase
0%Blood bilirubin unconjugated increased
0%Blood iron decreased
0%Weight increased
0%Hypercreatininaemia
0%Red cell distribution width increased
0%Muscular weakness
0%Hypercalcaemia
0%Device dislocation
0%Hyperuricaemia
0%Hypoproteinaemia
0%Flank pain
0%Hypophosphataemia
0%Musculoskeletal chest pain
0%Agnosia
0%Skin papilloma
0%Myoclonus
0%Pelvic pain
0%Haematuria
0%Disturbance in social behaviour
0%Hydronephrosis
0%Renal pain
0%Endometrial hyperplasia
0%Urosepsis
0%Atrial fibrillation
0%Salmonellosis
0%Malignant ascites
0%Lymph node pain
0%Hydrocele
0%Peripheral swelling
0%Dyschezia
0%Early satiety
0%Feeling abnormal
0%Gait disturbance
0%Performance status decreased
0%Autoimmune disorder
0%Gingivitis
0%Gastrointestinal infection
0%Blood potassium increased
0%Feeding intolerance
0%Neck pain
0%Lipoma
0%Nasal congestion
0%Dermatitis allergic
0%Xeroderma
0%Phlebitis
0%Atrial tachycardia
0%Disseminated intravascular coagulation
0%Oesophageal obstruction
0%Cholestasis
0%Influenza
0%Peritonitis bacterial
0%Subileus
0%Gastrointestinal obstruction
0%Sepsis
0%Lymphoedema
0%Respiratory failure
0%Presyncope
0%Lymphadenopathy
0%Bone marrow failure
0%Proctalgia
0%Non-Cardiac chest pain
0%Catheter site pain
0%Feeling cold
0%Facial pain
0%Candida infection
0%Hyperthermia
0%Lung infection
0%Localised infection
0%Vulvovaginal candidiasis
0%Iron deficiency
0%Vitamin d deficiency
0%Muscle spasms
0%Intervertebral disc compression
0%Intervertebral disc disorder
0%Soft tissue disorder
0%Osteoarthritis
0%Musculoskeletal stiffness
0%Tumour associated fever
0%Monoplegia
0%Encephalopathy
0%Neuralgia
0%Amnesia
0%Burning sensation
0%Sciatica
0%Drug abuse
0%Hallucination
0%Albuminuria
0%Urinary incontinence
0%Leukocyturia
0%Microalbuminuria
0%Micturition disorder
0%Nocturia
0%Pelvic discomfort
0%Vaginal haemorrhage
0%Rhinitis allergic
0%Rhinorrhoea
0%Tachypnoea
0%Respiratory disorder
0%Sputum discoloured
0%Blister
0%Wheezing
0%Acne
0%Onychoclasis
0%Hand dermatitis
0%Nail discolouration
0%Rash maculo-papular
0%Skin lesion
0%Thrombophlebitis
0%Raynaud's phenomenon
0%Urticaria
0%Hot flush
0%Disease progression
0%Ulcerative gastritis
0%Gastric ulcer haemorrhage
0%Pancreatitis
0%Oesophagitis
0%Large intestinal obstruction
0%Escherichia sepsis
0%Cerebrovascular accident
0%Renal failure
0%Depressed level of consciousness
0%Cerebral haemorrhage
0%Dry eye
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02500043) in the TAS-102+BSC ARM group. Side effects include: Anaemia with 42%, Neutropenia with 38%, Nausea with 37%, Decreased appetite with 33%, Fatigue with 26%.

Trial Design

1 Treatment Group

TAS-102
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: TAS-102 · No Placebo Group · Phase 2

TAS-102
Drug
Experimental Group · 1 Intervention: TAS-102 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS-102
2016
Completed Phase 3
~2150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Closest Location: MD Anderson Cancer Center · Houston, TX
Photo of MD Anderson Cancer Center 1Photo of MD Anderson Cancer Center 2Photo of MD Anderson Cancer Center 3
2004First Recorded Clinical Trial
0 TrialsResearching Colorectal Cancer
520 CompletedClinical Trials

Who is running the clinical trial?

TaihoUNKNOWN
M.D. Anderson Cancer CenterLead Sponsor
2,772 Previous Clinical Trials
1,794,502 Total Patients Enrolled
Arvind Dasari, MDStudy ChairM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no evidence of radiographic disease within 28 days (before or after) a positive ctDNA assay.
You have minimal residual disease as defined by positive ctDNA assay (completed as standard-of-care at MD Anderson) at least 3 months after completion of adjuvant chemotherapy.
Total bilirubin is within institutional ULN.
You have a serum creatinine concentration of 1.5 times the upper limit of normal (ULN) or greater, or a creatinine clearance of greater than 60 mL/min.
You have completed all planned adjuvant therapies.
You have a platelet count of at least 100,000/mcL.
You have a documented negative-ctDNA assay at completion of curative therapy.
AST/ALT ratio > 3:1 or institutional ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.