Trial · NCT02261532
A Phase I Study of TAS-102 in Solid Tumors
NCT02261532, Phase 1, Completed, Taiho Pharmaceutical Co., Ltd.; results first posted 2024-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I Study of TAS-102 in Solid Tumors. Trials, record NCT02261532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02261532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Study of TAS-102 in Solid Tumors
- NCT number
- NCT02261532
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- TAS-102
- First posted
- 2014-10-10
- Last updated
- 2024-11-14
- Results first posted
- 2024-10-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax (Maximum Plasma Concentration) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. | |
| Primary | Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. | |
| Primary | AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax (Maximum Plasma Concentration) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. | ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. | hours | GEOMETRIC_MEAN | |
| PRIMARY | AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. | ng·hr/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax (Maximum Plasma Concentration) of FTD | TAS-102 | Day 1 | 3019.49 | Geometric Coefficient of Variation 34.0 | ng/mL |
| Cmax (Maximum Plasma Concentration) of FTD | TAS-102 | Day 12 | 3693.08 | Geometric Coefficient of Variation 21.7 | ng/mL |
| Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | TAS-102 | Day 1 | 1.00 | Geometric Coefficient of Variation 58.7 | hours |
| Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | TAS-102 | Day 12 | 2.61 | Geometric Coefficient of Variation 36.2 | hours |
| AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD | TAS-102 | Day 1 | 7796.60 | Geometric Coefficient of Variation 19.1 | ng·hr/mL |
| AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD | TAS-102 | Day 12 | 18181.34 | Geometric Coefficient of Variation 30.0 | ng·hr/mL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS-102 | 15 | |
| Overall Study | COMPLETED | TAS-102 | 15 | |
| Overall Study | NOT COMPLETED | TAS-102 | 0 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | TAS-102 | 12 | 15 | |
| other | Vomiting | Gastrointestinal disorders | TAS-102 | 9 | 15 | |
| other | Constipation | Gastrointestinal disorders | TAS-102 | 5 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | TAS-102 | 3 | 15 | |
| other | Abdominal distension | Gastrointestinal disorders | TAS-102 | 2 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | TAS-102 | 2 | 15 | |
| other | Abdominal pain upper | Gastrointestinal disorders | TAS-102 | 2 | 15 | |
| other | Flatulence | Gastrointestinal disorders | TAS-102 | 1 | 15 | |
| other | Gastric dilatation | Gastrointestinal disorders | TAS-102 | 1 | 15 | |
| other | Large intestinal obstruction | Gastrointestinal disorders | TAS-102 | 1 | 15 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS-102 | 0 | 15 |
| Total, other adverse events | TAS-102 | 14 | 15 |
| Total, serious adverse events | TAS-102 | 4 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32308505 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02261532
GET https://conductscience.org/api/trials/v1/NCT02261532/events?page=2