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Nucleoside analog

TAS-102 for Tumors

Phase 1
Waitlist Available
Led By Nataliya Uboha, MD
Research Sponsored by University of Wisconsin, Madison
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 up to 5 years
Awards & highlights

Study Summary

This study is evaluating whether a combination of two drugs may be more effective than either drug alone.

Eligible Conditions
  • Tumors
  • Neuroendocrine Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Maximum Tolerated Dose (MTD) of TAS-102
Part 2: Overall Response Rate
Secondary outcome measures
Part 2: Biochemical Response defined as normalization or >50% reduction in levels of Chromogranin A
Part 2: Disease Control Rate
Part 2: Duration of Response
+3 more

Side effects data

From 2019 Phase 3 trial • 507 Patients • NCT02500043
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%
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: TAS-102 and TMZExperimental Treatment4 Interventions
Part 1: dose-escalation phase to determine MTD of TAS-102 in combination with Temozolomide (TMZ). Treatment cycles are 28 days, with TAS-102 administered orally twice daily days 1-5 and 8-12, and TMZ administered orally days 8-12. No treatment medications administered days 13-28 of each cycle. Growth factor support is required during Part 1 and should be dosed per institutional standards. Part 2: expansion phase to evaluate preliminary efficacy of MTD. Subjects treated with the recommended phase 2 drug doses determined in part 1. Treatment will continue for up to 13 cycles (approx. 12 months). Growth factor support is allowed during Part 2 and should be dosed per institutional standards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
TAS-102
2019
Completed Phase 3
~2170
Pegfilgrastim
2013
Completed Phase 3
~4410
Filgrastim
2000
Completed Phase 3
~3670

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,528 Total Patients Enrolled
Taiho Pharmaceutical Co., Ltd.Industry Sponsor
63 Previous Clinical Trials
16,280 Total Patients Enrolled
Nataliya Uboha, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs
2017. "Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02943733.
~2 spots leftby Apr 2025
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