Trial · NCT00652054
Phase 2 Study of S-1 as 2nd Line Therapy in Metastatic Pancreatic Cancer
NCT00652054, Phase 2, Completed, Taiho Oncology, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of S-1 as 2nd Line Therapy in Metastatic Pancreatic Cancer. Trials, record NCT00652054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00652054
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of S-1 as 2nd Line Therapy in Metastatic Pancreatic Cancer
- NCT number
- NCT00652054
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- S-1
- First posted
- 2008-04-03
- Last updated
- 2024-09-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR) | Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. Tumor assessmentswill be obtained at baseline) and at the end of every even cycle. | |
| Secondary | To evaluate the duration of response (DR), progress-free survival (PFS), and survival rate | Each cycle will last 21 days (14 days treatment, 7 days recovery for 6 mos. Pts will be followed for survival status every 2 months following PD for up to 6 mos. | |
| Secondary | To investigate the effect of S-1 on Karnofsky Performance Status (KPS), weight, and analgesic consumption | KPS and wt measured at baseline; w/in 24 hrs pr study drug on Day 1 of each cycle after Cycle 1; end of study treatment. Info on analgesics gathered at least 7 days prior to Day 1 of Cycle 1 and continuing through end of treatment. | |
| Secondary | To evaluate CA19-9 decline | Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. CA19-9 levels will be collected at basleine, Day 1 of each cycle, and at the end of treatment. | |
| Secondary | To evaluate the safety profile of S-1 | AEs will be reported from the time a patient signs informed consent through the period of patient follow-up Blood/urine will be collected at baseline; Days 8&15; w/in 24 hrs of study drug on Day 1 of each cycle after Cycle 1; at end of study treatment. | |
| Secondary | To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters | Each cycle will last 21 days (14 days treatment, 7 days recovery) for 6 mos. Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT00652054
GET https://conductscience.org/api/trials/v1/NCT00652054/registered