Trial · NCT00651742
Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer
NCT00651742, Phase 2, Completed, Taiho Oncology, Inc.; results first posted 2021-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer. Trials, record NCT00651742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00651742
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer
- NCT number
- NCT00651742
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Locally Advanced or Metastatic Pancreatic Cancer
- Interventions
- S-1
- First posted
- 2008-04-03
- Last updated
- 2024-09-19
- Results first posted
- 2021-12-10
- Limitations and caveats
- Since the pre-defined tumor response futility criteria was not exceeded in Stage 1, participant enrollment for Stage 2 was not conducted, as pre-planned in the protocol.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Tumor Response Rate (ORR) | 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 | 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. |
| Secondary | Disease Control Rate (DCR) | 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 | 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. |
| Secondary | Duration of Response (DR) | 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 | 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. |
| Secondary | Time to Tumor Progression (TTP) | 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 | 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. |
| Secondary | Overall Survival (OS) | 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 | 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. |
| Secondary | Progression-free Survival (PFS) | 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 | 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. |
| Secondary | Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score | Baseline, at end of treatment (up to 2 years 5 months) | 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. |
| Secondary | Change From Baseline in Pain Intensity | Baseline, at end of treatment (up to 2 years 5 months) | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | 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) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Tumor Response Rate (ORR) | 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 | 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. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | 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 | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants in the specified population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | 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 | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants evaluable in specified category. | months | MEDIAN |
| SECONDARY | Time to Tumor Progression (TTP) | 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 | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 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 | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | 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 | Analysis was performed on primary efficacy population. Here, 'Number analyzed' signifies number of participants in the specified population. | months | MEDIAN |
| SECONDARY | Number of Participants With Karnofsky Performance Status (KPS) Score - Shift From Baseline Score to Final Assessment Score | Baseline, at end of treatment (up to 2 years 5 months) | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Pain Intensity | Baseline, at end of treatment (up to 2 years 5 months) | Analysis was performed on safety population that included all the participants who had received at least one dose of study medication. | millimeters (mm) | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Tumor Response Rate (ORR) | S-1 30 mg/m^2 | Independent Assessment | 4.0 | 95% Confidence Interval 0.1 to 20.4 | percentage of participants |
| Overall Tumor Response Rate (ORR) | S-1 30 mg/m^2 | Investigator Assessment | 9.5 | 95% Confidence Interval 1.2 to 30.4 | percentage of participants |
| Disease Control Rate (DCR) | S-1 30 mg/m^2 | Independent Assessment | 68.0 | 95% Confidence Interval 46.5 to 85.1 | percentage of participants |
| Disease Control Rate (DCR) | S-1 30 mg/m^2 | Investigator Assessment | 76.2 | 95% Confidence Interval 52.8 to 91.8 | percentage of participants |
| Duration of Response (DR) | S-1 30 mg/m^2 | Independent Assessment | 7.4 | 95% Confidence Interval NA to NA | months |
| Duration of Response (DR) | S-1 30 mg/m^2 | Investigator Assessment | NA | 95% Confidence Interval 2.8 to NA | months |
| Time to Tumor Progression (TTP) | S-1 30 mg/m^2 | Independent Assessment | 3.5 | 95% Confidence Interval 1.6 to 5.5 | months |
| Time to Tumor Progression (TTP) | S-1 30 mg/m^2 | Investigator Assessment | 3.5 | 95% Confidence Interval 2.5 to 5.3 | months |
| Overall Survival (OS) | S-1 30 mg/m^2 | 9.1 | 95% Confidence Interval 4.7 to 11.2 | months | |
| Progression-free Survival (PFS) | S-1 30 mg/m^2 | Independent Assessment | 3.5 | 95% Confidence Interval 1.6 to 5.5 | months |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | S-1 30 mg/m^2 | 28 | |
| Overall Study | Treated | S-1 30 mg/m^2 | 27 | |
| Overall Study | Efficacy Analysis Per Investigator | S-1 30 mg/m^2 | 21 | |
| Overall Study | Efficacy Analysis Per Independent Reader | S-1 30 mg/m^2 | 25 | |
| Overall Study | COMPLETED | S-1 30 mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | S-1 30 mg/m^2 | 28 |
Source ClinicalTrials.gov
Adverse events79
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 | S-1 30 mg/m^2 | 4 | 27 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | S-1 30 mg/m^2 | 4 | 27 | 6 |
| other | Lymphopenia | Blood and lymphatic system disorders | S-1 30 mg/m^2 | 3 | 27 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | S-1 30 mg/m^2 | 4 | 27 | 4 |
| other | Vertigo | Ear and labyrinth disorders | S-1 30 mg/m^2 | 2 | 27 | 3 |
| other | Conjunctivitis | Eye disorders | S-1 30 mg/m^2 | 3 | 27 | 3 |
| other | Lacrimation increased | Eye disorders | S-1 30 mg/m^2 | 6 | 27 | 6 |
| other | Abdominal distension | Gastrointestinal disorders | S-1 30 mg/m^2 | 3 | 27 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | S-1 30 mg/m^2 | 3 | 27 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | S-1 30 mg/m^2 | 7 | 27 | 8 |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S-1 30 mg/m^2 | 24 | 27 |
| Total, other adverse events | S-1 30 mg/m^2 | 25 | 27 |
| Total, serious adverse events | S-1 30 mg/m^2 | 15 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00651742
GET https://conductscience.org/api/trials/v1/NCT00651742/results?page=2