Trial · NCT01092728
Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
NCT01092728, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2016-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma. Trials, record NCT01092728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01092728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
- NCT number
- NCT01092728
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Melanoma
- Interventions
- Dasatinib, Surgical Resection
- First posted
- 2010-03-25
- Last updated
- 2016-09-05
- Results first posted
- 2016-09-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biologic Response Evaluation of Tumors With and Without Resectable Tumors | Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards | Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, \>/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without \>15% increase in tumoral Ki-67 expression or \>/=25% decrease in tumoral Ki-67 expression without \>15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): \>/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image \& adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background. PR or CR confirmatory disease assessment performed \>4 weeks (28 days) after criteria for response first met. |
| Secondary | Progression-Free Survival | Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years | Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress. |
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 | Biologic Response Evaluation of Tumors With and Without Resectable Tumors | Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards | Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal). | participants | NUMBER |
| SECONDARY | Progression-Free Survival | Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years | None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study. | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Biologic Response Evaluation of Tumors With and Without Resectable Tumors | Dasatinib + Unresectable | Complete Metabolic Response | 0 | participants | |
| Biologic Response Evaluation of Tumors With and Without Resectable Tumors | Dasatinib + Unresectable | Partial Metabolic Response | 1 | participants | |
| Progression-Free Survival | Dasatinib + Unresectable | 8.00 | Full Range 0.86 to 89.57 | Weeks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib + Completely Resectable | 4 | |
| Overall Study | STARTED | Dasatinib + Unresectable | 14 | |
| Overall Study | COMPLETED | Dasatinib + Completely Resectable | 0 | |
| Overall Study | COMPLETED | Dasatinib + Unresectable | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib + Completely Resectable | 4 | |
| Overall Study | NOT COMPLETED | Dasatinib + Unresectable | 14 |
Source ClinicalTrials.gov
Adverse events100
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 | Platelet Count Decreased | Blood and lymphatic system disorders | Dasatinib + Completely Resectable | 0 | 4 | 0 |
| other | Platelet Count Decreased | Blood and lymphatic system disorders | Dasatinib + Unresectable | 1 | 14 | 1 |
| other | Vaginal Hemorrhage | Reproductive system and breast disorders | Dasatinib + Completely Resectable | 0 | 4 | 0 |
| other | Vaginal Hemorrhage | Reproductive system and breast disorders | Dasatinib + Unresectable | 1 | 14 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Dasatinib + Completely Resectable | 1 | 4 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Dasatinib + Unresectable | 3 | 14 | 3 |
| other | Hemoglobin Decreased | Metabolism and nutrition disorders | Dasatinib + Completely Resectable | 0 | 4 | 0 |
| other | Hemoglobin Decreased | Metabolism and nutrition disorders | Dasatinib + Unresectable | 1 | 14 | 1 |
| other | Edema Limbs | Blood and lymphatic system disorders | Dasatinib + Completely Resectable | 0 | 4 | 0 |
| other | Edema Limbs | Blood and lymphatic system disorders | Dasatinib + Unresectable | 7 | 14 | 7 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib + Completely Resectable | ||
| Total, all-cause mortality | Dasatinib + Unresectable | ||
| Total, other adverse events | Dasatinib + Completely Resectable | 4 | 4 |
| Total, other adverse events | Dasatinib + Unresectable | 14 | 14 |
| Total, serious adverse events | Dasatinib + Completely Resectable | 0 | 4 |
| Total, serious adverse events | Dasatinib + Unresectable | 4 | 14 |
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 + Completely Resectable vs Dasatinib + Unresectable: 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/NCT01092728
GET https://conductscience.org/api/trials/v1/NCT01092728/events?page=2