Trial · NCT01395017
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
NCT01395017, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2015-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer. Trials, record NCT01395017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01395017
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
- NCT number
- NCT01395017
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 202 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Pancreatic Cancer
- Interventions
- dasatinib, Placebo
- First posted
- 2011-07-15
- Last updated
- 2016-04-08
- Results first posted
- 2015-03-17
- Limitations and caveats
5 participants (who had not experienced disease progression at the time of event-driven data cut-off) were told the study results and were instructed to indicate sponsor discontinued study if they did not want to continue in the study.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until date of death from any cause by 02 December 2013 | Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013. |
| Secondary | Progression Free Survival (PFS) | Time from randomization to earliest PFS event by 02 December 2013 | PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until date of death from any cause by 02 December 2013 | The intent-to-treat (ITT) data which was composed of all randomized participants. | Days | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Time from randomization to earliest PFS event by 02 December 2013 | The ITT data which was composed of all randomized participants. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Dasatinib + GEM | 375 | 95% Confidence Interval 310 to 450 | Days | |
| Overall Survival | Placebo + GEM | 393 | 95% Confidence Interval 356 to 467 | Days | |
| Progression Free Survival (PFS) | Dasatinib + GEM | 167 | 95% Confidence Interval 114 to 212 | Days | |
| Progression Free Survival (PFS) | Placebo + GEM | 166 | 95% Confidence Interval 160 to 199 | Days |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib + GEM | 100 | |
| Overall Study | STARTED | Placebo + GEM | 102 | |
| Overall Study | Treated | Dasatinib + GEM | 98 | |
| Overall Study | Treated | Placebo + GEM | 101 | |
| Overall Study | COMPLETED | Dasatinib + GEM | 0 | |
| Overall Study | COMPLETED | Placebo + GEM | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib + GEM | 100 | |
| Overall Study | NOT COMPLETED | Placebo + GEM | 102 |
Source ClinicalTrials.gov
Adverse events350
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 | Anemia | Blood and lymphatic system disorders | Dasatinib + GEM | 50 | 98 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo + GEM | 28 | 101 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dasatinib + GEM | 8 | 98 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + GEM | 13 | 101 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dasatinib + GEM | 5 | 98 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + GEM | 7 | 101 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dasatinib + GEM | 53 | 98 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + GEM | 49 | 101 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dasatinib + GEM | 38 | 98 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + GEM | 39 | 101 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib + GEM | ||
| Total, all-cause mortality | Placebo + GEM | ||
| Total, other adverse events | Dasatinib + GEM | 93 | 98 |
| Total, other adverse events | Placebo + GEM | 98 | 101 |
| Total, serious adverse events | Dasatinib + GEM | 53 | 98 |
| Total, serious adverse events | Placebo + GEM | 48 | 101 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dasatinib + GEM vs Placebo + GEM: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01395017
GET https://conductscience.org/api/trials/v1/NCT01395017/events?page=2