Your session is about to expire
← Back to Search
Topoisomerase I inhibitors
ctDNA-Guided Therapy for Colorectal Cancer
Phase 1
Recruiting
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
Performance status: ECOG performance status ≤2
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug combination to see if it is effective in patients with ctDNA positive colon adenocarcinoma.
Who is the study for?
This trial is for adults with colon adenocarcinoma who have completed at least 3 months of adjuvant chemotherapy and are ctDNA positive. They must be able to swallow tablets, have a life expectancy over 3 months, and an ECOG performance status ≤2. Women of childbearing potential must use contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of TAS-102 combined with irinotecan in patients with ctDNA positive colon adenocarcinoma after surgery. It's a phase 1b trial where all participants receive this combination treatment without being randomly assigned to different groups.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding tendencies, liver enzyme changes, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
My colorectal cancer is at Stage II, III, or IV and I'm eligible for additional chemotherapy after surgery.
Select...
My blood and organ functions are within the required ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chemotherapy, Adjuvant
Secondary outcome measures
Percentage of Grade 3-5 Adverse Events
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%
Dyspnoea
6%
Hypoalbuminaemia
6%
Weight decreased
6%
Lymphopenia
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%
Dysgeusia
3%
Cough
3%
Malaise
3%
Hyperglycaemia
3%
Hypocalcaemia
3%
Hyperbilirubinaemia
3%
Blood creatinine increased
3%
Pleural effusion
3%
Urinary tract infection
3%
Anxiety
3%
Insomnia
2%
Oedema
2%
Hypomagnesaemia
2%
Dizziness
2%
Arthralgia
2%
Headache
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%
Urinary retention
1%
Oesophageal pain
1%
Hyponatraemia
1%
Somnolence
1%
Impaired gastric emptying
1%
Dry skin
1%
Chills
1%
Tumour pain
1%
Dysphonia
1%
Jaundice
1%
Pneumonia
1%
Musculoskeletal pain
1%
Septic shock
1%
Fall
1%
Haemoglobin decreased
1%
Pain in extremity
1%
Dyspnoea exertional
1%
Flatulence
1%
Productive cough
1%
Small intestinal obstruction
1%
Pulmonary embolism
1%
Obstruction gastric
1%
Odynophagia
1%
Rectal haemorrhage
1%
Pain
1%
Respiratory tract infection
1%
Epistaxis
1%
Tumour haemorrhage
1%
Protein total decreased
1%
Dehydration
1%
Abdominal discomfort
1%
Nasopharyngitis
1%
Dyspepsia
1%
Dry mouth
1%
Choluria
1%
Liver disorder
1%
Tonsillitis
1%
Haemorrhoidal haemorrhage
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: TASIRIExperimental Treatment4 Interventions
Patients randomized to the experimental arm ("TASIRI") will be treated with TAS-102 25mg/m2 p.o. on days 1-5 and irinotecan 180mg/m2 i.v. on day 1 every 14 days. If ANC <1500/uL on day 1 of a cycle, then G-CSF will be added on day 6 for three days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Treatment
2014
Completed Phase 4
~2720
TAS-102
2019
Completed Phase 3
~2170
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
Natera, Inc.Industry Sponsor
47 Previous Clinical Trials
42,345 Total Patients Enrolled
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,021 Total Patients Enrolled
Taiho Pharmaceutical Co., Ltd.Industry Sponsor
63 Previous Clinical Trials
16,276 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood test shows cancer markers after 3 months of chemotherapy.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I can take care of myself but might not be able to do heavy physical work.I can swallow pills.I haven't had major surgery in the last 4 weeks or chemotherapy/radiotherapy in the last 2 weeks.I am 18 years old or older.My cancer is a type of colon cancer confirmed by lab tests.My cancer has spread to other parts of my body.My colorectal cancer is at Stage II, III, or IV and I'm eligible for additional chemotherapy after surgery.My blood and organ functions are within the required ranges.I have previously been treated with irinotecan or TAS-102.All my side effects from cancer treatment have mostly gone, except for hair loss.I haven't had another cancer, except for certain skin, prostate, or cervical cancers, in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: TASIRI
Awards:
This trial has 1 awards, including:- 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.
What has been the traditional application of TAS-102?
"TAS-102 is widely used to address glioblastoma multiforme (gbm). This medication can be utilized for other medical conditions such as blepharitis, pharmacotherapy, and eyelid structure."
Answered by AI
Is there an opportunity for enrolment in this clinical research endeavor?
"Clinicaltrials.gov confirms that this research study is actively seeking participants - it was first posted on August 26th 2021 and the most recent update occurred on May 24th 2022."
Answered by AI
Has the Food and Drug Administration granted approval for TAS-102?
"The safety rating for TAS-102 is 1 due to this being a Phase 1 trial, indicating that the efficacy and safety have limited clinical data supporting them."
Answered by AI
Could you provide details about previous experiments that utilized TAS-102?
"Presently, there are 297 different clinical trials being conducted for TAS-102. Of this number, 56 have reached the third stage of research. While most of these studies take place in Adelaide, South Australia; globally, 9069 locations are running trials involving this medication."
Answered by AI
How many participants are involved in this clinical trial?
"Affirmative. According to clinicaltrials.gov, the trial launched on August 26th 2021 and was recently modified on May 24th 2022 is actively seeking participants for recruitment. 22 patients must be recruited from a single medical centre."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger