SOLAR: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Sponsor
Taiho Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02322593
Collaborator
Yakult Honsha Co., LTD (Industry)
711
6
2
65
118.5
1.8
Study Details
Study Description
Brief Summary
The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
711 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
Actual Study Start Date
:
Dec 1, 2014
Actual Primary Completion Date
:
Feb 1, 2019
Actual Study Completion Date
:
May 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAS-118/Oxaliplatin TAS-118 plus Oxaliplatin |
Drug: TAS-118 plus Oxaliplatin
|
| Active Comparator: S-1/Cisplatin S-1 plus Cisplatin |
Drug: S-1 plus Cisplatin
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.]
The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.
Secondary Outcome Measures
- Progression-free Survival [A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.]
PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first.
- Time to Treatment Failure [From the date of randomization to the date of the last administration of the study drug.]
TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier.
- Overall Response Rate [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.]
ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions
- Disease Control Rate [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.]
DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Patients who are diagnosed as gastric cancer.
-
No prior treatment for gastric cancer.
-
Negative or unknown for HER2 testing.
-
ECOG performance status of 0 or 1.
Key Exclusion Criteria:
-
Unmanageable diarrhea.
-
Current peripheral sensory neuropathy or paresthesia.
-
Pregnant or lactating female.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taiho Pharmaceutical Co., Ltd selected site | Ibaraki | Japan | 305-8576 | |
| 2 | Taiho Pharmaceutical Co., Ltd selected site | Kumamoto | Japan | 860-8556 | |
| 3 | Taiho Pharmaceutical Co., Ltd selected site | Tokyo | Japan | 104-0045 | |
| 4 | Taiho Pharmaceutical Co., Ltd selected site | Seoul | Korea, Republic of | 110-744 | |
| 5 | Taiho Pharmaceutical Co., Ltd selected site | Seoul | Korea, Republic of | 120-752 | |
| 6 | Taiho Pharmaceutical Co., Ltd selected site | Seoul | Korea, Republic of | 138-736 |
Sponsors and Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Yakult Honsha Co., LTD
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02322593
Other Study ID Numbers:
- 10056040
First Posted:
Dec 23, 2014
Last Update Posted:
Dec 20, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Taiho Pharmaceutical Co., Ltd.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin |
|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. |
| Period Title: Overall Study | ||
| STARTED | 356 | 355 |
| COMPLETED | 356 | 355 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin | Total |
|---|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | Total of all reporting groups |
| Overall Participants | 347 | 334 | 681 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
201
57.9%
|
194
58.1%
|
395
58%
|
| >=65 years |
146
42.1%
|
140
41.9%
|
286
42%
|
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
62.0
|
62.0
|
62.0
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
96
27.7%
|
116
34.7%
|
212
31.1%
|
| Male |
251
72.3%
|
218
65.3%
|
469
68.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
347
100%
|
334
100%
|
681
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
347
100%
|
334
100%
|
681
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Japan |
221
63.7%
|
212
63.5%
|
433
63.6%
|
| South Korea |
126
36.3%
|
122
36.5%
|
248
36.4%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent. |
| Time Frame | A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization. |
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin |
|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. |
| Measure Participants | 347 | 334 |
| Median (95% Confidence Interval) [Months] |
16.0
|
15.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TAS-118/Oxaliplatin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 0.99 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.091 |
|
| Estimation Comments | ||
| Title | Progression-free Survival |
|---|---|
| Description | PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first. |
| Time Frame | A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first. |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin |
|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. |
| Measure Participants | 347 | 334 |
| Median (95% Confidence Interval) [Months] |
7.1
|
6.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TAS-118/Oxaliplatin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0045 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 0.93 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.086 |
|
| Estimation Comments | ||
| Title | Time to Treatment Failure |
|---|---|
| Description | TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier. |
| Time Frame | From the date of randomization to the date of the last administration of the study drug. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin |
|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. |
| Measure Participants | 347 | 334 |
| Median (95% Confidence Interval) [Months] |
6.1
|
5.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TAS-118/Oxaliplatin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 0.96 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.078 |
|
| Estimation Comments | ||
| Title | Overall Response Rate |
|---|---|
| Description | ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions |
| Time Frame | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Tumor Response (TR) Evaluable Population： Patients in FAS population presenting measurable lesions (at least one target lesion), evaluated for tumor responses at least once during treatment with the study drug. |
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin |
|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. |
| Measure Participants | 211 | 212 |
| Count of Participants [Participants] |
155
44.7%
|
106
31.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TAS-118/Oxaliplatin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Disease Control Rate |
|---|---|
| Description | DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions. |
| Time Frame | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TR Evaluable Population： |
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin |
|---|---|---|
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. |
| Measure Participants | 211 | 212 |
| Count of Participants [Participants] |
197
56.8%
|
187
56%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TAS-118/Oxaliplatin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.092 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | From the time a patient signed informed consent until 30 day safety follow-up visit or initiation of new anticancer treatment, whichever was earlier, an average assessed up to 42 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | An adverse event (AE) is any untoward medical condition that occurs in a patient while participating in a clinical study and does not necessarily have a causal relationship with the use of the product. Treatment emergent adverse events are AEs that occur from the initiation of any study medication administration, and do not necessarily have a causal relationship to the use of the study medication. | |||
| Arm/Group Title | TAS-118/Oxaliplatin | S-1/Cisplatin | ||
| Arm/Group Description | TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met. | ||
All Cause Mortality |
||||
| TAS-118/Oxaliplatin | S-1/Cisplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/352 (6.3%) | 8/348 (2.3%) | ||
Serious Adverse Events |
||||
| TAS-118/Oxaliplatin | S-1/Cisplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 155/352 (44%) | 159/348 (45.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/352 (0.6%) | 5/348 (1.4%) | ||
| Disseminated intravascular coagulation | 3/352 (0.9%) | 0/348 (0%) | ||
| Febrile neutropenia | 4/352 (1.1%) | 6/348 (1.7%) | ||
| Lymphadenitis | 0/352 (0%) | 1/348 (0.3%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/352 (0%) | 1/348 (0.3%) | ||
| Prinzmetal angina | 0/352 (0%) | 1/348 (0.3%) | ||
| Eye disorders | ||||
| Rhegmatogenous retinal detachment | 1/352 (0.3%) | 0/348 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 0/352 (0%) | 3/348 (0.9%) | ||
| Abdominal pain | 10/352 (2.8%) | 9/348 (2.6%) | ||
| Abdominal pain upper | 1/352 (0.3%) | 0/348 (0%) | ||
| Ascites | 5/352 (1.4%) | 8/348 (2.3%) | ||
| Cheilitis | 1/352 (0.3%) | 0/348 (0%) | ||
| Colitis | 1/352 (0.3%) | 0/348 (0%) | ||
| Diarrhoea | 14/352 (4%) | 8/348 (2.3%) | ||
| Dyspepsia | 0/352 (0%) | 1/348 (0.3%) | ||
| Dysphagia | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Enteritis | 5/352 (1.4%) | 2/348 (0.6%) | ||
| Enterocolitis | 3/352 (0.9%) | 0/348 (0%) | ||
| Gastric haemorrhage | 3/352 (0.9%) | 2/348 (0.6%) | ||
| Gastric perforation | 0/352 (0%) | 3/348 (0.9%) | ||
| Gastric ulcer haemorrhage | 0/352 (0%) | 1/348 (0.3%) | ||
| Gastrointestinal haemorrhage | 0/352 (0%) | 2/348 (0.6%) | ||
| Gastrointestinal necrosis | 1/352 (0.3%) | 0/348 (0%) | ||
| Gastrointestinal perforation | 0/352 (0%) | 1/348 (0.3%) | ||
| Haematemesis | 1/352 (0.3%) | 0/348 (0%) | ||
| Haematochezia | 1/352 (0.3%) | 0/348 (0%) | ||
| Ileus | 7/352 (2%) | 5/348 (1.4%) | ||
| Ileus paralytic | 0/352 (0%) | 1/348 (0.3%) | ||
| Inguinal hernia | 0/352 (0%) | 1/348 (0.3%) | ||
| Large intestine perforation | 0/352 (0%) | 1/348 (0.3%) | ||
| Nausea | 11/352 (3.1%) | 6/348 (1.7%) | ||
| Obstruction gastric | 3/352 (0.9%) | 8/348 (2.3%) | ||
| Pancreatitis | 1/352 (0.3%) | 0/348 (0%) | ||
| Rectal stenosis | 0/352 (0%) | 1/348 (0.3%) | ||
| Small intestinal obstruction | 0/352 (0%) | 3/348 (0.9%) | ||
| Stomatitis | 0/352 (0%) | 2/348 (0.6%) | ||
| Vomiting | 4/352 (1.1%) | 1/348 (0.3%) | ||
| Oesophageal discomfort | 1/352 (0.3%) | 0/348 (0%) | ||
| Haemorrhoidal haemorrhage | 1/352 (0.3%) | 0/348 (0%) | ||
| Gastric stenosis | 2/352 (0.6%) | 4/348 (1.1%) | ||
| Large intestinal obstruction | 2/352 (0.6%) | 0/348 (0%) | ||
| Rectal obstruction | 0/352 (0%) | 1/348 (0.3%) | ||
| Large intestinal stenosis | 2/352 (0.6%) | 0/348 (0%) | ||
| General disorders | ||||
| Asthenia | 4/352 (1.1%) | 2/348 (0.6%) | ||
| Condition aggravated | 1/352 (0.3%) | 0/348 (0%) | ||
| Death | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Fatigue | 3/352 (0.9%) | 4/348 (1.1%) | ||
| Malaise | 2/352 (0.6%) | 2/348 (0.6%) | ||
| Mucosal inflammation | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Mucous membrane disorder | 1/352 (0.3%) | 0/348 (0%) | ||
| Oedema peripheral | 0/352 (0%) | 1/348 (0.3%) | ||
| Pain | 1/352 (0.3%) | 0/348 (0%) | ||
| Pyrexia | 10/352 (2.8%) | 5/348 (1.4%) | ||
| Disease progression | 5/352 (1.4%) | 1/348 (0.3%) | ||
| Complication associated with device | 1/352 (0.3%) | 0/348 (0%) | ||
| Hepatobiliary disorders | ||||
| Bile duct stone | 0/352 (0%) | 1/348 (0.3%) | ||
| Cholangitis | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Cholangitis acute | 1/352 (0.3%) | 0/348 (0%) | ||
| Cholecystitis | 0/352 (0%) | 1/348 (0.3%) | ||
| Cholecystitis acute | 0/352 (0%) | 1/348 (0.3%) | ||
| Hepatic failure | 1/352 (0.3%) | 0/348 (0%) | ||
| Hepatic function abnormal | 1/352 (0.3%) | 2/348 (0.6%) | ||
| Jaundice | 0/352 (0%) | 1/348 (0.3%) | ||
| Jaundice cholestatic | 3/352 (0.9%) | 1/348 (0.3%) | ||
| Bile duct stenosis | 0/352 (0%) | 1/348 (0.3%) | ||
| Bile duct obstruction | 0/352 (0%) | 1/348 (0.3%) | ||
| Biliary dilatation | 1/352 (0.3%) | 0/348 (0%) | ||
| Infections and infestations | ||||
| Appendicitis | 2/352 (0.6%) | 0/348 (0%) | ||
| Atypical pneumonia | 1/352 (0.3%) | 0/348 (0%) | ||
| Dacryocystitis | 0/352 (0%) | 1/348 (0.3%) | ||
| Diverticulitis | 0/352 (0%) | 1/348 (0.3%) | ||
| Infection | 1/352 (0.3%) | 0/348 (0%) | ||
| Influenza | 1/352 (0.3%) | 0/348 (0%) | ||
| Peritonitis | 2/352 (0.6%) | 0/348 (0%) | ||
| Pneumonia | 8/352 (2.3%) | 7/348 (2%) | ||
| Pneumonia herpes viral | 1/352 (0.3%) | 0/348 (0%) | ||
| Pneumonia pneumococcal | 0/352 (0%) | 1/348 (0.3%) | ||
| Pulmonary tuberculosis | 2/352 (0.6%) | 0/348 (0%) | ||
| Sepsis | 3/352 (0.9%) | 2/348 (0.6%) | ||
| Upper respiratory tract infection | 1/352 (0.3%) | 0/348 (0%) | ||
| Urethritis | 0/352 (0%) | 1/348 (0.3%) | ||
| Urinary tract infection | 4/352 (1.1%) | 1/348 (0.3%) | ||
| Cytomegalovirus enterocolitis | 1/352 (0.3%) | 0/348 (0%) | ||
| Cytomegalovirus enteritis | 0/352 (0%) | 1/348 (0.3%) | ||
| Enterocolitis infectious | 0/352 (0%) | 1/348 (0.3%) | ||
| Enteritis infectious | 1/352 (0.3%) | 0/348 (0%) | ||
| Pneumonia bacterial | 1/352 (0.3%) | 0/348 (0%) | ||
| Lung infection | 1/352 (0.3%) | 3/348 (0.9%) | ||
| Biliary tract infection | 0/352 (0%) | 1/348 (0.3%) | ||
| Peritonitis bacterial | 0/352 (0%) | 1/348 (0.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Compression fracture | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Femur fracture | 2/352 (0.6%) | 0/348 (0%) | ||
| Fractured ischium | 1/352 (0.3%) | 0/348 (0%) | ||
| Humerus fracture | 0/352 (0%) | 1/348 (0.3%) | ||
| Jaw fracture | 0/352 (0%) | 1/348 (0.3%) | ||
| Rib fracture | 1/352 (0.3%) | 0/348 (0%) | ||
| Subarachnoid haemorrhage | 1/352 (0.3%) | 0/348 (0%) | ||
| Toxicity to various agents | 0/352 (0%) | 1/348 (0.3%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 1/352 (0.3%) | 0/348 (0%) | ||
| Aspartate aminotransferase increased | 1/352 (0.3%) | 0/348 (0%) | ||
| Blood bilirubin increased | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Neutrophil count decreased | 0/352 (0%) | 6/348 (1.7%) | ||
| Platelet count decreased | 0/352 (0%) | 1/348 (0.3%) | ||
| Weight decreased | 1/352 (0.3%) | 0/348 (0%) | ||
| White blood cell count decreased | 0/352 (0%) | 1/348 (0.3%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 5/352 (1.4%) | 6/348 (1.7%) | ||
| Diabetic ketoacidosis | 0/352 (0%) | 1/348 (0.3%) | ||
| Hyperglycaemia | 0/352 (0%) | 2/348 (0.6%) | ||
| Hypoalbuminaemia | 1/352 (0.3%) | 0/348 (0%) | ||
| Hyponatraemia | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Malnutrition | 0/352 (0%) | 1/348 (0.3%) | ||
| Decreased appetite | 39/352 (11.1%) | 32/348 (9.2%) | ||
| Hypophagia | 1/352 (0.3%) | 3/348 (0.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Back pain | 1/352 (0.3%) | 0/348 (0%) | ||
| Pathological fracture | 0/352 (0%) | 1/348 (0.3%) | ||
| Spinal column stenosis | 1/352 (0.3%) | 0/348 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignant ascites | 0/352 (0%) | 1/348 (0.3%) | ||
| Tumour pain | 1/352 (0.3%) | 2/348 (0.6%) | ||
| Tumour haemorrhage | 3/352 (0.9%) | 3/348 (0.9%) | ||
| Metastases to meninges | 5/352 (1.4%) | 1/348 (0.3%) | ||
| Tumour associated fever | 0/352 (0%) | 1/348 (0.3%) | ||
| Cancer pain | 1/352 (0.3%) | 1/348 (0.3%) | ||
| Metastatic gastric cancer | 1/352 (0.3%) | 0/348 (0%) | ||
| Nervous system disorders | ||||
| Cerebral infarction | 0/352 (0%) | 2/348 (0.6%) | ||
| Dementia | 0/352 (0%) | 1/348 (0.3%) | ||
| Depressed level of consciousness | 0/352 (0%) | 1/348 (0.3%) | ||
| Dizziness | 2/352 (0.6%) | 0/348 (0%) | ||
| Dysarthria | 1/352 (0.3%) | 0/348 (0%) | ||
| Headache | 1/352 (0.3%) | 0/348 (0%) | ||
| Loss of consciousness | 0/352 (0%) | 2/348 (0.6%) | ||
| Peripheral sensory neuropathy | 2/352 (0.6%) | 0/348 (0%) | ||
| Presyncope | 0/352 (0%) | 2/348 (0.6%) | ||
| Seizure | 0/352 (0%) | 1/348 (0.3%) | ||
| Status epilepticus | 0/352 (0%) | 1/348 (0.3%) | ||
| Syncope | 0/352 (0%) | 1/348 (0.3%) | ||
| Embolic cerebral infarction | 0/352 (0%) | 1/348 (0.3%) | ||
| Partial seizures | 0/352 (0%) | 1/348 (0.3%) | ||
| Psychiatric disorders | ||||
| Delirium | 0/352 (0%) | 1/348 (0.3%) | ||
| Suicide attempt | 1/352 (0.3%) | 0/348 (0%) | ||
| Mental disorder | 1/352 (0.3%) | 0/348 (0%) | ||
| Renal and urinary disorders | ||||
| Hydronephrosis | 4/352 (1.1%) | 8/348 (2.3%) | ||
| Renal disorder | 0/352 (0%) | 1/348 (0.3%) | ||
| Urinary tract obstruction | 0/352 (0%) | 2/348 (0.6%) | ||
| Renal impairment | 0/352 (0%) | 1/348 (0.3%) | ||
| Acute kidney injury | 0/352 (0%) | 2/348 (0.6%) | ||
| Reproductive system and breast disorders | ||||
| Adnexal torsion | 0/352 (0%) | 1/348 (0.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 2/352 (0.6%) | 3/348 (0.9%) | ||
| Hiccups | 0/352 (0%) | 1/348 (0.3%) | ||
| Interstitial lung disease | 2/352 (0.6%) | 0/348 (0%) | ||
| Pleural effusion | 1/352 (0.3%) | 0/348 (0%) | ||
| Pneumonia aspiration | 1/352 (0.3%) | 2/348 (0.6%) | ||
| Pulmonary embolism | 3/352 (0.9%) | 4/348 (1.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermatomyositis | 0/352 (0%) | 1/348 (0.3%) | ||
| Drug eruption | 0/352 (0%) | 1/348 (0.3%) | ||
| Rash | 1/352 (0.3%) | 0/348 (0%) | ||
| Vascular disorders | ||||
| Embolism | 0/352 (0%) | 2/348 (0.6%) | ||
| Infarction | 1/352 (0.3%) | 0/348 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| TAS-118/Oxaliplatin | S-1/Cisplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 344/352 (97.7%) | 328/348 (94.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 94/352 (26.7%) | 96/348 (27.6%) | ||
| Leukopenia | 14/352 (4%) | 19/348 (5.5%) | ||
| Neutropenia | 50/352 (14.2%) | 53/348 (15.2%) | ||
| Eye disorders | ||||
| Lacrimation increased | 41/352 (11.6%) | 37/348 (10.6%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 46/352 (13.1%) | 30/348 (8.6%) | ||
| Constipation | 80/352 (22.7%) | 90/348 (25.9%) | ||
| Diarrhoea | 189/352 (53.7%) | 134/348 (38.5%) | ||
| Dyspepsia | 20/352 (5.7%) | 13/348 (3.7%) | ||
| Nausea | 200/352 (56.8%) | 186/348 (53.4%) | ||
| Stomatitis | 148/352 (42%) | 88/348 (25.3%) | ||
| Vomiting | 100/352 (28.4%) | 70/348 (20.1%) | ||
| General disorders | ||||
| Fatigue | 116/352 (33%) | 106/348 (30.5%) | ||
| Malaise | 77/352 (21.9%) | 76/348 (21.8%) | ||
| Oedema | 9/352 (2.6%) | 26/348 (7.5%) | ||
| Oedema peripheral | 21/352 (6%) | 27/348 (7.8%) | ||
| Pyrexia | 45/352 (12.8%) | 32/348 (9.2%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 45/352 (12.8%) | 20/348 (5.7%) | ||
| Aspartate aminotransferase increased | 50/352 (14.2%) | 19/348 (5.5%) | ||
| Blood creatinine increased | 6/352 (1.7%) | 33/348 (9.5%) | ||
| Neutrophil count decreased | 90/352 (25.6%) | 115/348 (33%) | ||
| Platelet count decreased | 103/352 (29.3%) | 76/348 (21.8%) | ||
| Weight decreased | 78/352 (22.2%) | 41/348 (11.8%) | ||
| White blood cell count decreased | 45/352 (12.8%) | 76/348 (21.8%) | ||
| Blood alkaline phosphatase increased | 27/352 (7.7%) | 10/348 (2.9%) | ||
| Metabolism and nutrition disorders | ||||
| Hypoalbuminaemia | 40/352 (11.4%) | 25/348 (7.2%) | ||
| Hypokalaemia | 19/352 (5.4%) | 14/348 (4%) | ||
| Hyponatraemia | 7/352 (2%) | 19/348 (5.5%) | ||
| Decreased appetite | 234/352 (66.5%) | 216/348 (62.1%) | ||
| Nervous system disorders | ||||
| Dizziness | 18/352 (5.1%) | 34/348 (9.8%) | ||
| Dysgeusia | 112/352 (31.8%) | 82/348 (23.6%) | ||
| Neuropathy peripheral | 21/352 (6%) | 7/348 (2%) | ||
| Peripheral sensory neuropathy | 242/352 (68.8%) | 54/348 (15.5%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Hiccups | 19/352 (5.4%) | 62/348 (17.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 11/352 (3.1%) | 23/348 (6.6%) | ||
| Palmar-plantar erythrodysaesthesia syndrome | 60/352 (17%) | 27/348 (7.8%) | ||
| Rash | 18/352 (5.1%) | 19/348 (5.5%) | ||
| Skin hyperpigmentation | 63/352 (17.9%) | 50/348 (14.4%) | ||
| Pigmentation disorder | 32/352 (9.1%) | 17/348 (4.9%) | ||
| Vascular disorders | ||||
| Vascular pain | 32/352 (9.1%) | 9/348 (2.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Taiho Pharmaceutical Co., Ltd. |
|---|---|
| Organization | Clinical Trial Registration Contact |
| Phone | |
| toiawase@taiho.co.jp |
Responsible Party:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02322593
Other Study ID Numbers:
- 10056040
First Posted:
Dec 23, 2014
Last Update Posted:
Dec 20, 2021
Last Verified:
Nov 1, 2021