Trial Outcomes & Findings for A Phase I Study of TAS-102 in Solid Tumors (NCT NCT02261532)
NCT ID: NCT02261532
Last Updated: 2024-11-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Multiple time points on Day 1 and Day 12 of Cycle 1.
Results posted on
2024-11-14
Participant Flow
Participant milestones
| Measure |
TAS-102
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Study of TAS-102 in Solid Tumors
Baseline characteristics by cohort
| Measure |
TAS-102
n=15 Participants
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
Age, Continuous
|
56.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Multiple time points on Day 1 and Day 12 of Cycle 1.Outcome measures
| Measure |
TAS-102
n=14 Participants
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
Cmax (Maximum Plasma Concentration) of FTD
Day 1
|
3019.49 ng/mL
Geometric Coefficient of Variation 34.0
|
|
Cmax (Maximum Plasma Concentration) of FTD
Day 12
|
3693.08 ng/mL
Geometric Coefficient of Variation 21.7
|
PRIMARY outcome
Timeframe: Multiple time points on Day 1 and Day 12 of Cycle 1.Outcome measures
| Measure |
TAS-102
n=14 Participants
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
Day 1
|
1.00 hours
Geometric Coefficient of Variation 58.7
|
|
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
Day 12
|
2.61 hours
Geometric Coefficient of Variation 36.2
|
PRIMARY outcome
Timeframe: Multiple time points on Day 1 and Day 12 of Cycle 1.Outcome measures
| Measure |
TAS-102
n=14 Participants
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
Day 1
|
7796.60 ng·hr/mL
Geometric Coefficient of Variation 19.1
|
|
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
Day 12
|
18181.34 ng·hr/mL
Geometric Coefficient of Variation 30.0
|
Adverse Events
TAS-102
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAS-102
n=15 participants at risk
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • 15 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 15 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.7%
1/15 • 15 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • 15 weeks
|
|
General disorders
Fatigue
|
6.7%
1/15 • 15 weeks
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • 15 weeks
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • 15 weeks
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 15 weeks
|
Other adverse events
| Measure |
TAS-102
n=15 participants at risk
TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
80.0%
12/15 • 15 weeks
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
9/15 • 15 weeks
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • 15 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
3/15 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
13.3%
2/15 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.3%
2/15 • 15 weeks
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • 15 weeks
|
|
Gastrointestinal disorders
Gastric dilatation
|
6.7%
1/15 • 15 weeks
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
6.7%
1/15 • 15 weeks
|
|
Investigations
Neutrophil count decreased
|
26.7%
4/15 • 15 weeks
|
|
Investigations
White blood cell count decreased
|
26.7%
4/15 • 15 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • 15 weeks
|
|
Investigations
Haemoglobin decreased
|
13.3%
2/15 • 15 weeks
|
|
Investigations
Platelet count decreased
|
13.3%
2/15 • 15 weeks
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • 15 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • 15 weeks
|
|
Investigations
Protein urine present
|
6.7%
1/15 • 15 weeks
|
|
Investigations
Urine bilirubin increased
|
6.7%
1/15 • 15 weeks
|
|
General disorders
Fatigue
|
46.7%
7/15 • 15 weeks
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • 15 weeks
|
|
General disorders
Pyrexia
|
6.7%
1/15 • 15 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.7%
7/15 • 15 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
3/15 • 15 weeks
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.7%
1/15 • 15 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • 15 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
5/15 • 15 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
5/15 • 15 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • 15 weeks
|
|
Blood and lymphatic system disorders
Erythropenia
|
13.3%
2/15 • 15 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.7%
1/15 • 15 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • 15 weeks
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • 15 weeks
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 15 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
1/15 • 15 weeks
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • 15 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
13.3%
2/15 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.7%
1/15 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • 15 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • 15 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15 • 15 weeks
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • 15 weeks
|
Additional Information
Clinical Trial Registration Contact
Taiho Pharmaceutical co., ltd.
Phone: +81-3-3293-2113
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place