Trial · NCT02428855
Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma
NCT02428855, Phase 2, Completed, Massachusetts General Hospital; results first posted 2020-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma. Trials, record NCT02428855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02428855
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma
- NCT number
- NCT02428855
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Cholangiocarcinoma
- Interventions
- Dasatinib
- First posted
- 2015-04-29
- Last updated
- 2020-07-31
- Results first posted
- 2020-07-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 8 Weeks | The number of participants that achieved either a complete or partial response, as assessed by Response Criteria in Solid Tumors (RECIST 1.1) * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Median Progression Free Survival (PFS) | From registration until disease progression or death, median duration of 8.7 weeks | The median amount of time from registration until disease progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 criteria: \> Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Overall Survival | From the time of registration until death, median duration of 37.9 weeks | The median amount of time from registration until death. Participants are censored at the date last known alive. |
| Secondary | Number of Participants With Adverse Events | From the start of treatment until 30 days after the end of treatment, median duration of 3 months | The number of participants that experienced an adverse event as assessed by Common Toxicology Criteria for Adverse Events (CTCAE 4.0) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | 8 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Progression Free Survival (PFS) | From registration until disease progression or death, median duration of 8.7 weeks | Weeks | MEDIAN | |
| SECONDARY | Overall Survival | From the time of registration until death, median duration of 37.9 weeks | Weeks | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | From the start of treatment until 30 days after the end of treatment, median duration of 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Dasatinib | Complete Response (CR) | 0 | Participants | |
| Objective Response Rate (ORR) | Dasatinib | Partial Response (CR) | 0 | Participants | |
| Median Progression Free Survival (PFS) | Dasatinib | 8.7 | 95% Confidence Interval 6.4 to NA | Weeks | |
| Overall Survival | Dasatinib | 37.9 | 95% Confidence Interval 20.7 to NA | Weeks | |
| Number of Participants With Adverse Events | Dasatinib | 8 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 8 | |
| Overall Study | COMPLETED | Dasatinib | 6 | |
| Overall Study | NOT COMPLETED | Dasatinib | 2 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Lymphopenia | Blood and lymphatic system disorders | Dasatinib | 4 | 8 | |
| serious | Anemia | Blood and lymphatic system disorders | Dasatinib | 1 | 8 | |
| serious | Hyponatremia | Metabolism and nutrition disorders | Dasatinib | 1 | 8 | |
| serious | Hypophosphatemia | Metabolism and nutrition disorders | Dasatinib | 1 | 8 | |
| serious | Aspartate aminotransferase increased | Investigations | Dasatinib | 1 | 8 | |
| serious | Menorrhagia | Reproductive system and breast disorders | Dasatinib | 1 | 8 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | 7 | 8 |
| Total, other adverse events | Dasatinib | 0 | 8 |
| Total, serious adverse events | Dasatinib | 8 | 8 |
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/NCT02428855
GET https://conductscience.org/api/trials/v1/NCT02428855/registered