Trial · NCT01607957

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

NCT01607957, Phase 3, Completed, Taiho Oncology, Inc.; results first posted 2019-05-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies. Trials, record NCT01607957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01607957

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
NCT number: NCT01607957
Status: Completed
Phases: Phase 3
Enrollment: 800 participants, actual
Lead sponsor: Taiho Oncology, Inc.
Conditions: Colorectal Cancer
Interventions: TAS-102, Placebo
First posted: 2012-05-30
Last updated: 2024-09-19
Other registries' IDs: eudract:2012-000109-66
Results first posted: 2019-05-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)	Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
Secondary	Progression-free Survival	Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)	Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.
Secondary	Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.

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	Overall Survival	Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)	Analysis was performed in ITT population. For participants who were alive as of the overall survival cutoff date, their survival was censored on the cutoff date post consent.	months	MEDIAN
SECONDARY	Progression-free Survival	Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)	Analysis was performed in ITT population.	months	MEDIAN
SECONDARY	Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier	Safety analysis was performed on as treated (AT) population including all participants who took part of any dose of the study medication.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	TAS-102		7.1	95% Confidence Interval 6.5 to 7.8	months
Overall Survival	Placebo		5.3	95% Confidence Interval 4.6 to 6.0	months
Progression-free Survival	TAS-102		2.0	95% Confidence Interval 1.9 to 2.1	months
Progression-free Survival	Placebo		1.7	95% Confidence Interval 1.7 to 1.8	months
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	TAS-102	Any adverse event (AE)	98.3		percentage of participants
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	Placebo	Any adverse event (AE)	93.2		percentage of participants
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	TAS-102	Any treatment-related AE	85.7		percentage of participants
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	Placebo	Any treatment-related AE	54.7		percentage of participants
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	TAS-102	Any ≥Grade 3 AE	69.4		percentage of participants
Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths	Placebo	Any ≥Grade 3 AE	51.7		percentage of participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TAS-102	534
Overall Study	STARTED	Placebo	266
Overall Study	Treated	TAS-102	533
Overall Study	Treated	Placebo	265
Overall Study	COMPLETED	TAS-102	162
Overall Study	COMPLETED	Placebo	51
Overall Study	NOT COMPLETED	TAS-102	372
Overall Study	NOT COMPLETED	Placebo	215

Source ClinicalTrials.gov

Adverse events378

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	Anaemia	Blood and lymphatic system disorders	TAS-102	205	533	265
other	Anaemia	Blood and lymphatic system disorders	Placebo	22	265	24
other	Leukopenia	Blood and lymphatic system disorders	TAS-102	27	533	34
other	Leukopenia	Blood and lymphatic system disorders	Placebo	0	265	0
other	Neutropenia	Blood and lymphatic system disorders	TAS-102	152	533	327
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	265	0
other	Thrombocytopenia	Blood and lymphatic system disorders	TAS-102	35	533	58
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	1	265	1
other	Abdominal pain	Gastrointestinal disorders	TAS-102	74	533	83
other	Abdominal pain	Gastrointestinal disorders	Placebo	32	265	32

1 to 10 of 378Source ClinicalTrials.gov

See all 378 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAS-102	17	533
Total, all-cause mortality	Placebo	30	265
Total, other adverse events	TAS-102	506	533
Total, other adverse events	Placebo	227	265
Total, serious adverse events	TAS-102	158	533
Total, serious adverse events	Placebo	89	265

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25970050	DERIVED	PubMed
27443414	DERIVED	PubMed
29274618	DERIVED	PubMed
31912801	DERIVED	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TAS-102 vs Placebo: deaths from any cause	Trial comparisons
TAS-102 vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01607957

GET https://conductscience.org/api/trials/v1/NCT01607957/events?page=2

API reference For AI assistants