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Anti-tumor antibiotic
TAS-102 for Gastroesophageal Cancer
Phase 1
Waitlist Available
Led By Farshid Dayyani, MD, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is effective and safe. It is for people with stomach or throat cancer who have already tried other treatments that haven't worked.
Eligible Conditions
- Gastroesophageal Cancer
- Stomach Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Progression-free Survival at 6 Months
Secondary outcome measures
Number of Participants With Grade 3-5 Adverse Events
Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan
Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan
Side effects data
From 2019 Phase 3 trial • 507 Patients • NCT0250004342%
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%
Abdominal pain upper
7%
White blood cell count decreased
7%
Pyrexia
7%
Back pain
6%
Hypoalbuminaemia
6%
Dyspnoea
6%
Lymphopenia
6%
Weight decreased
6%
General physical health deterioration
6%
Aspartate aminotransferase increased
5%
Blood bilirubin increased
5%
Oedema peripheral
5%
Alanine aminotransferase increased
5%
Ascites
4%
Stomatitis
4%
Dysphagia
4%
Abdominal distension
4%
Alopecia
3%
Hypokalaemia
3%
Cough
3%
Malaise
3%
Hyperglycaemia
3%
Hypocalcaemia
3%
Dysgeusia
3%
Hyperbilirubinaemia
3%
Blood creatinine increased
3%
Pleural effusion
3%
Urinary tract infection
3%
Anxiety
3%
Insomnia
2%
Oedema
2%
Arthralgia
2%
Headache
2%
Hypomagnesaemia
2%
Dizziness
2%
Oral candidiasis
2%
Pancytopenia
2%
Palpitations
2%
Blood urea increased
2%
Paraesthesia
2%
Pruritus
2%
Hypotension
2%
Mucosal inflammation
2%
Upper respiratory tract infection
1%
Septic shock
1%
Oesophageal pain
1%
Pneumonia
1%
Fall
1%
Hyponatraemia
1%
Pulmonary embolism
1%
Somnolence
1%
Urinary retention
1%
Dry skin
1%
Chills
1%
Productive cough
1%
Tumour haemorrhage
1%
Musculoskeletal pain
1%
Haemoglobin decreased
1%
Pain in extremity
1%
Tumour pain
1%
Dyspnoea exertional
1%
Small intestinal obstruction
1%
Obstruction gastric
1%
Haemorrhoidal haemorrhage
1%
Odynophagia
1%
Rectal haemorrhage
1%
Pain
1%
Respiratory tract infection
1%
Epistaxis
1%
Protein total decreased
1%
Dehydration
1%
Jaundice
1%
Abdominal discomfort
1%
Flatulence
1%
Nasopharyngitis
1%
Dyspepsia
1%
Dry mouth
1%
Choluria
1%
Liver disorder
1%
Impaired gastric emptying
1%
Tonsillitis
1%
Dysphonia
1%
Melaena
1%
Toothache
1%
Acute coronary syndrome
1%
Tachycardia
1%
Bronchitis
1%
Infection
1%
Febrile neutropenia
1%
Shock haemorrhagic
1%
Abdominal pain lower
1%
Gastrooesophageal reflux disease
1%
Herpes zoster
1%
Groin pain
1%
Conjunctivitis
1%
Lymphocyte count decreased
1%
Hepatic enzyme increased
1%
Cachexia
1%
Pneumonia aspiration
1%
Neutropenic sepsis
1%
Haematemesis
1%
Spinal pain
1%
Cancer pain
1%
Pallor
1%
Vertigo
1%
Cystitis
1%
Decubitus ulcer
1%
Dermatitis
1%
Myocardial infarction
1%
Gastric haemorrhage
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Failure to thrive
1%
Enzyme level increased
1%
Gamma-Glutamyltransferase increased
1%
Bone pain
1%
Myalgia
1%
Lethargy
1%
Neuropathy peripheral
1%
Peripheral sensory neuropathy
1%
Hiccups
1%
Oropharyngeal pain
1%
Nail disorder
1%
Night sweats
1%
Palmar-Plantar erythrodysaesthesia syndrome
1%
Rash
1%
Deep vein thrombosis
1%
Embolism
1%
Hypertension
1%
Metastases to central nervous system
1%
Chest discomfort
1%
Chest pain
1%
Ileus
1%
Intestinal obstruction
1%
Hepatic failure
1%
Lower respiratory tract infection
1%
Rhinitis
1%
Red blood cell count decreased
1%
Muscle atrophy
1%
Agitation
1%
Confusional state
1%
Delirium
1%
Depression
1%
Acute kidney injury
1%
Dysuria
1%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAS-102+BSC
Placebo+BSC
Trial Design
1Treatment groups
Experimental Treatment
Group I: TAS-102 and IrinotecanExperimental Treatment2 Interventions
Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
TAS-102
2019
Completed Phase 3
~2170
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,981 Total Patients Enrolled
Taiho Pharmaceutical Co., Ltd.Industry Sponsor
63 Previous Clinical Trials
16,278 Total Patients Enrolled
Farshid Dayyani, MD, PhD5.02 ReviewsPrincipal Investigator - Chao Family Comprehensive Cancer Center
University of California, Irvine
3 Previous Clinical Trials
77 Total Patients Enrolled
5Patient Review
Dr. Sayyani is successfully managing the side effects of my chemotherapy and is very patient-focused. He listens to our questions and does his best to answer them, even if he doesn't have all the answers.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any records of preceding trials involving TAS-102?
"Currently, 297 investigations pertaining to TAS-102 are ongoing, with 56 of them in their final stage. Adelaide is a hub for this research; yet there exists an aggregate of 9069 medical centres that have taken part in trials regarding the drug's efficacy."
Answered by AI
What maladies does TAS-102 typically address?
"TAS-102 is frequently prescribed to treat glioblastoma multiforme (gbm). Additionally, its efficacy has been observed in treating blepharitis, pharmacotherapy and eyelid structure."
Answered by AI
How does TAS-102 affect human health and well-being?
"TAS-102's safety score was 1, as there is limited data backing its efficacy and no prior studies assessing the medication's safety."
Answered by AI
What is the uppermost capacity of participants in this research endeavor?
"At this time, no further participants are being sought for the clinical trial first posted on August 26th 2019 and updated April 4th 2022. Those interested in participating in an adenocarcinoma study can view 795 active trials, while TAS-102 has 297 open studies."
Answered by AI
Are there any available slots for individuals to join this clinical trial?
"Unfortunately, this study has already closed its recruitment period. It was posted online on August 26th 2019 and last updated on April 4th 2022. For those still interested in taking part in a trial there are 795 studies for adenocarcinoma and 297 trials using TAS-102 actively recruiting patients."
Answered by AI
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