Trial · NCT02500043
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
NCT02500043, Phase 3, Completed, Taiho Oncology, Inc.; results first posted 2021-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer. Trials, record NCT02500043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02500043
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
- NCT number
- NCT02500043
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 507 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Refractory Metastatic Gastric Cancer
- Interventions
- TAS-102, Placebo
- First posted
- 2015-07-16
- Last updated
- 2024-09-03
- Other registries' IDs
- eudract:2015-002683-16
- Results first posted
- 2021-09-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months) | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method. |
| Secondary | Progression-Free Survival (PFS) | From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months) | PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months) | Any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study medication was considered an adverse event (AE). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs/TESAEs were defined as events that started on or after treatment or started before treatment and worsened after the start of treatment through 30 days after the last dose of study treatment. |
| Other | Overall Response Rate (ORR) | From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks | Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \< 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference. |
| Other | Disease Control Rate (DCR) | From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks | DCR was defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). The assessment of DCR was based on Investigator review of radiologic images and following RECIST criteria (version 1.1, 2009). |
| Other | Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline | At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months) | The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for \< 50% of the time; 3= in bed for \> 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to \>=2, or from 2 to \>=3. |
| Other | Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status | Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months) | EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant. |
| Other | EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance | Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months) | The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months) | Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months) | Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months) | Analysis was performed on the As-treated (AT) population that included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Overall Response Rate (ORR) | From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks | Analysis was performed on tumor response (TR) population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline). | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Disease Control Rate (DCR) | From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks | Analysis was performed on TR population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline). | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline | At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months) | Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status | Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months) | Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance | Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months) | Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | TAS-102+BSC | 5.7 | 95% Confidence Interval 4.8 to 6.2 | months | |
| Overall Survival (OS) | Placebo+BSC | 3.6 | 95% Confidence Interval 3.1 to 4.1 | months | |
| Progression-Free Survival (PFS) | TAS-102+BSC | 2.0 | 95% Confidence Interval 1.9 to 2.3 | months | |
| Progression-Free Survival (PFS) | Placebo+BSC | 1.8 | 95% Confidence Interval 1.7 to 1.9 | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | TAS-102+BSC | TEAE | 319 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | Placebo+BSC | TEAE | 151 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | TAS-102+BSC | TESAE | 143 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) | Placebo+BSC | TESAE | 70 | Participants | |
| Overall Response Rate (ORR) | TAS-102+BSC | 4.5 | 95% Confidence Interval 2.4 to 7.5 | percentage of participants | |
| Overall Response Rate (ORR) | Placebo+BSC | 2.1 | 95% Confidence Interval 0.4 to 5.9 | percentage of participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS-102+BSC | 337 | |
| Overall Study | STARTED | Placebo+BSC | 170 | |
| Overall Study | As-Treated (AT) Population | TAS-102+BSC | 335 | |
| Overall Study | As-Treated (AT) Population | Placebo+BSC | 168 | |
| Overall Study | COMPLETED | TAS-102+BSC | 0 | |
| Overall Study | COMPLETED | Placebo+BSC | 0 | |
| Overall Study | NOT COMPLETED | TAS-102+BSC | 337 | |
| Overall Study | NOT COMPLETED | Placebo+BSC | 170 |
Source ClinicalTrials.gov
Adverse events934
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+BSC | 142 | 335 | 249 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo+BSC | 30 | 168 | 52 |
| other | Bone marrow failure | Blood and lymphatic system disorders | TAS-102+BSC | 1 | 335 | 1 |
| other | Bone marrow failure | Blood and lymphatic system disorders | Placebo+BSC | 0 | 168 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | TAS-102+BSC | 1 | 335 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Placebo+BSC | 0 | 168 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | TAS-102+BSC | 2 | 335 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo+BSC | 0 | 168 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | TAS-102+BSC | 57 | 335 | 116 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo+BSC | 3 | 168 | 14 |
1 to 10 of 934Source ClinicalTrials.gov
See all 934 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS-102+BSC | 252 | 335 |
| Total, all-cause mortality | Placebo+BSC | 141 | 168 |
| Total, other adverse events | TAS-102+BSC | 319 | 335 |
| Total, other adverse events | Placebo+BSC | 151 | 168 |
| Total, serious adverse events | TAS-102+BSC | 143 | 335 |
| Total, serious adverse events | Placebo+BSC | 70 | 168 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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+BSC vs Placebo+BSC: deaths from any cause | Trial comparisons |
| TAS-102+BSC vs Placebo+BSC: 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.
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/NCT02500043
GET https://conductscience.org/api/trials/v1/NCT02500043/results?page=2