Trial Outcomes & Findings for Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer (NCT NCT00651742)
NCT ID: NCT00651742
Last Updated: 2024-09-19
Results Overview
ORR was defined as the percentage of participants with objective evidence of partial response (PR) or complete response (CR) and was based on the best overall response across all cycles for each participant. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST). For target lesions response, CR was defined as the disappearance of all target lesions for at least 3 weeks and PR was defined as at least a 30% reduction in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum of the longest diameters for at least 6 weeks. For non-target lesions, CR was defined the disappearance of all non-target lesions and normalization of tumor marker level for at least 6 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months
Results posted on
2024-09-19
Participant Flow
The study was conducted at 9 centers in the Germany between 09-January-2006 to 08-July-2008.
The enrollment of Stage 2 of the study was not initiated, as sufficient efficacy per protocol was not demonstrated in Stage 1. Overall, 29 participants were screened, of them 28 participants were enrolled and 27 received study treatment in Stage 1.
Participant milestones
| Measure |
S-1 30 mg/m^2
Participants received 30 milligrams per meter square (mg/m\^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
Treated
|
27
|
|
Overall Study
Efficacy Analysis Per Investigator
|
21
|
|
Overall Study
Efficacy Analysis Per Independent Reader
|
25
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
S-1 30 mg/m^2
Participants received 30 milligrams per meter square (mg/m\^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Overall Study
Objective Disease Progression
|
22
|
|
Overall Study
Toxicity
|
3
|
|
Overall Study
Investigator Judgment
|
1
|
|
Overall Study
Withdrawal of Consent
|
1
|
|
Overall Study
Enrolled but not treated
|
1
|
Baseline Characteristics
Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 monthsPopulation: Primary efficacy population included all participants in the safety population who met the key eligibility criteria (1st line therapy in participants with measurable pancreatic locally advanced or metastatic disease) and had at least one response assessment after starting study treatment. Here, 'Number analyzed' signifies number of participants in the specified population.
ORR was defined as the percentage of participants with objective evidence of partial response (PR) or complete response (CR) and was based on the best overall response across all cycles for each participant. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST). For target lesions response, CR was defined as the disappearance of all target lesions for at least 3 weeks and PR was defined as at least a 30% reduction in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum of the longest diameters for at least 6 weeks. For non-target lesions, CR was defined the disappearance of all non-target lesions and normalization of tumor marker level for at least 6 weeks.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Overall Tumor Response Rate (ORR)
Independent Assessment
|
4.0 percentage of participants
Interval 0.1 to 20.4
|
|
Overall Tumor Response Rate (ORR)
Investigator Assessment
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
SECONDARY outcome
Timeframe: From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 monthsPopulation: Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants in the specified population.
DCR was defined as the percentage of participants with objective evidence of CR, PR or stable disease (SD) determined according to RECIST. For target lesions, stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as a reference the smallest sum of the longest diameters since the treatment started for at least 6 weeks. For non-target lesions, stable disease was defined a persistence of greater than or equal to (\>=) 1 non-target lesions and/or maintenance of tumor marker level above the normal limits for at least 6 weeks.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Disease Control Rate (DCR)
Independent Assessment
|
68.0 percentage of participants
Interval 46.5 to 85.1
|
|
Disease Control Rate (DCR)
Investigator Assessment
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
SECONDARY outcome
Timeframe: From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 monthsPopulation: Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants evaluable in specified category.
DR was calculated as date of first progressive disease (PD) or death, date after the first response of CR or PR minus date of first CR or PR plus 1. Participants who did not die and were without progressive disease were censored at last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Duration of Response (DR)
Independent Assessment
|
7.4 months
Upper and lower limit of Confidence Interval (CI) is not estimable, due to less number of participants with event.
|
|
Duration of Response (DR)
Investigator Assessment
|
NA months
Interval 2.8 to
Median and upper limit of CI is not estimable, due to less number of participants with event.
|
SECONDARY outcome
Timeframe: From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 monthsPopulation: Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants evaluable for this outcome measure.
TTP was calculated as date of first PD minus date of first dose of study medication plus 1. Participants without progressive disease were censored at last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Time to Tumor Progression (TTP)
Investigator Assessment
|
3.5 months
Interval 2.5 to 5.3
|
|
Time to Tumor Progression (TTP)
Independent Assessment
|
3.5 months
Interval 1.6 to 5.5
|
SECONDARY outcome
Timeframe: From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 monthsPopulation: Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
OS was calculated as date of death minus date of first dose of study medication plus 1. In the absence of death confirmation, OS was censored at the date of last study follow-up. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Overall Survival (OS)
|
9.1 months
Interval 4.7 to 11.2
|
SECONDARY outcome
Timeframe: From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 monthsPopulation: Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants in the specified population.
PFS was defined as date of first PD or date of death minus date of first dose of study medication plus 1. Participants who did not die and were without PD were censored at their last evaluable tumor response assessment. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Progression-free Survival (PFS)
Independent Assessment
|
3.5 months
Interval 1.6 to 5.5
|
|
Progression-free Survival (PFS)
Investigator Assessment
|
3.5 months
Interval 2.5 to 5.3
|
SECONDARY outcome
Timeframe: Baseline, at end of treatment (up to 2 years 5 months)Population: Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
KPS classified participant's as per their functional impairment. The KPS ranged from 0percent (%) to 100%, (100= no signs of disease, 90% = few symptoms or signs of disease, 80%=some symptoms or signs, 70% = not capable of normal activity or work, 60% = can take care of most personal requirements, 50% = requires frequent medical care, 40% = disabled, 30% = severely disabled, hospital admission indicated but no risk of death, 20% = very ill, requires supportive measures or treatment, 10% = moribund, rapidly progressive fatal disease processes, and 0% = death), where higher values represented better outcomes. Participants with baseline KPS \>=70% were included in study. Final assessment was the participant's last assessment. Participants with available data were only presented in the below data table.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
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|---|---|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 100% shift to Final assessment score 100%
|
6 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 100% shift to Final assessment score 90%
|
7 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 100% shift to Final assessment score 70%
|
1 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 100% shift to Final assessment score 0%
|
1 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 90% shift to Final assessment score 90%
|
1 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 90% shift to Final assessment score 80%
|
3 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 90% shift to Final assessment score 70%
|
1 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 90% shift to Final assessment score 60%
|
1 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 90% shift to Final assessment score 0%
|
2 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 80% shift to Final assessment score 80%
|
1 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 80% shift to Final assessment score 0%
|
2 Participants
|
|
Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score
Baseline score 70% shift to Final assessment score 0%
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, at end of treatment (up to 2 years 5 months)Population: Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
Pain intensity was graded from 0 (least possible pain) to 100 (worst possible pain) on a visual analog scale (VAS). The higher score on VAS scale indicated more pain. Final assessment was the last assessment of participant's.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Change From Baseline in Pain Intensity
|
-6.47 millimeters (mm)
Standard Deviation 27.619
|
SECONDARY outcome
Timeframe: From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months)Population: Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
An AE was defined as any untoward medical event in a participants administered any dose of a study medication which may or may not have a causal relationship with the use of the study medication. An 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.
Outcome measures
| Measure |
S-1 30 mg/m^2
n=27 Participants
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
At Least 1 AE
|
25 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
At Least 1 SAE
|
15 Participants
|
Adverse Events
S-1 30 mg/m^2
Serious events: 15 serious events
Other events: 25 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
S-1 30 mg/m^2
n=27 participants at risk
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.8%
4/27 • Number of events 4 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
General disorders
Disease progression
|
14.8%
4/27 • Number of events 4 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
General disorders
Fatigue
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
General disorders
General physical health deterioration
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
General disorders
Pain
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholestasis
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Infections and infestations
Wound infection
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.7%
1/27 • Number of events 1 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
Other adverse events
| Measure |
S-1 30 mg/m^2
n=27 participants at risk
Participants received 30 mg/m\^2 of S-1 orally BID for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
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Blood and lymphatic system disorders
Anaemia
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14.8%
4/27 • Number of events 5 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Blood and lymphatic system disorders
Leukopenia
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14.8%
4/27 • Number of events 6 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Blood and lymphatic system disorders
Lymphopenia
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Blood and lymphatic system disorders
Thrombocytopenia
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14.8%
4/27 • Number of events 4 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Ear and labyrinth disorders
Vertigo
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7.4%
2/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Eye disorders
Conjunctivitis
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Eye disorders
Lacrimation increased
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22.2%
6/27 • Number of events 6 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Abdominal distension
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Abdominal pain
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Abdominal pain upper
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25.9%
7/27 • Number of events 8 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Ascites
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Colitis
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Constipation
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22.2%
6/27 • Number of events 6 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Diarrhoea
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33.3%
9/27 • Number of events 15 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Dry mouth
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Flatulence
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18.5%
5/27 • Number of events 6 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Nausea
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37.0%
10/27 • Number of events 15 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Pancreatic insufficiency
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Stomatitis
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11.1%
3/27 • Number of events 4 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Gastrointestinal disorders
Vomiting
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33.3%
9/27 • Number of events 13 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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General disorders
Asthenia
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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General disorders
Chills
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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General disorders
Fatigue
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37.0%
10/27 • Number of events 13 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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General disorders
General physical health deterioration
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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General disorders
Oedema peripheral
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14.8%
4/27 • Number of events 4 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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General disorders
Pyrexia
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14.8%
4/27 • Number of events 6 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Hepatobiliary disorders
Hepatic pain
|
7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Aspartate aminotransferase increased
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Blood alkaline phosphatase increased
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Blood bilirubin increased
|
11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Blood creatinine increased
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Blood urea increased
|
11.1%
3/27 • Number of events 4 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Haemoglobin decreased
|
11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Weight decreased
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33.3%
9/27 • Number of events 9 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Investigations
Weight increased
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Metabolism and nutrition disorders
Anorexia
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18.5%
5/27 • Number of events 5 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Metabolism and nutrition disorders
Hypocalcaemia
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Metabolism and nutrition disorders
Hypokalaemia
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14.8%
4/27 • Number of events 6 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Metabolism and nutrition disorders
Vitamin k deficiency
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Musculoskeletal and connective tissue disorders
Arthralgia
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Nervous system disorders
Dizziness
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Nervous system disorders
Headache
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Nervous system disorders
Syncope
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Psychiatric disorders
Depression
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11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Psychiatric disorders
Insomnia
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Psychiatric disorders
Sleep disorder
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7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Renal and urinary disorders
Dysuria
|
7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Reproductive system and breast disorders
Benign prostatic hyperplasia
|
7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
3/27 • Number of events 3 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
|
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Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.4%
2/27 • Number of events 2 • From the first dose of study medication up to 30 days after the last dose of study medication, or until additional antitumor therapy had been introduced, whichever came first (approximately up to 2 years 6 months).
Analysis was performed on safety population that included all the participants who had received at least one dose of study medication.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place