Trial · NCT00459108
Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
NCT00459108, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery. Trials, record NCT00459108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00459108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
- NCT number
- NCT00459108
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
- Interventions
- dasatinib
- First posted
- 2007-04-11
- Last updated
- 2018-04-19
- Results first posted
- 2015-03-20
- Limitations and caveats
- Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Complete and Partial Response) | 4 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR |
| Primary | Four Month Progression-free Survival (PFS) | 4 months | Progression-free survival calculated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Median Progression-free Survival | Until disease progression or death, up to 4 years | Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival | Up to 4 years | Estimated using the product-limit method of Kaplan and Meier. |
| Secondary | Safety and Tolerability | Up to 4 years | Summarize observed grade 3 and higher toxicities related to dasatanib. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were used for reporting. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (Complete and Partial Response) | 4 months | percentage of responding patients | NUMBER | |
| PRIMARY | Four Month Progression-free Survival (PFS) | 4 months | percentage of participants | NUMBER | |
| SECONDARY | Median Progression-free Survival | Until disease progression or death, up to 4 years | Months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 4 years | Months | MEDIAN | |
| SECONDARY | Safety and Tolerability | Up to 4 years | One patient died due to underlying cardiac disease which may have been exacerbated by the dasatanib. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Complete and Partial Response) | Oral Dasatinib | 0 | percentage of responding patients | ||
| Four Month Progression-free Survival (PFS) | Oral Dasatinib | 40 | 95% Confidence Interval 21 to 58 | percentage of participants | |
| Median Progression-free Survival | Oral Dasatinib | 3.7 | 95% Confidence Interval 1.8 to 6.4 | Months | |
| Overall Survival | Oral Dasatinib | 7.5 | 95% Confidence Interval 2.9 to 13.6 | Months | |
| Safety and Tolerability | Oral Dasatinib | Grade 3 : AST, SGOT | 2 | participants | |
| Safety and Tolerability | Oral Dasatinib | Grade 3 : Anorexia | 2 | participants | |
| Safety and Tolerability | Oral Dasatinib | Grade 3 : Sudden death | 0 | participants | |
| Safety and Tolerability | Oral Dasatinib | Grade 3 : Dehydration | 2 | participants | |
| Safety and Tolerability | Oral Dasatinib | Grade 3 : Diarrhea | 1 | participants | |
| Safety and Tolerability | Oral Dasatinib | Grade 3 : Dizziness | 0 | participants |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Dasatinib | 25 | |
| Overall Study | COMPLETED | Oral Dasatinib | 14 | |
| Overall Study | NOT COMPLETED | Oral Dasatinib | 11 |
Source ClinicalTrials.gov
Adverse events135
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Oral Dasatinib | 16 | 25 | 43 |
| other | Hemolysis | Blood and lymphatic system disorders | Oral Dasatinib | 1 | 25 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Oral Dasatinib | 1 | 25 | 2 |
| other | Dry eye syndrome | Eye disorders | Oral Dasatinib | 1 | 25 | 1 |
| other | Eye disorder | Eye disorders | Oral Dasatinib | 1 | 25 | 1 |
| other | Vision blurred | Eye disorders | Oral Dasatinib | 1 | 25 | 1 |
| other | Vitreous hemorrhage | Eye disorders | Oral Dasatinib | 1 | 25 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Oral Dasatinib | 3 | 25 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Oral Dasatinib | 11 | 25 | 18 |
| other | Ascites | Gastrointestinal disorders | Oral Dasatinib | 2 | 25 | 2 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Dasatinib | ||
| Total, other adverse events | Oral Dasatinib | 25 | 25 |
| Total, serious adverse events | Oral Dasatinib | 13 | 25 |
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/NCT00459108
GET https://conductscience.org/api/trials/v1/NCT00459108/results?page=2