Trial · NCT00700882
Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
NCT00700882, Phase 2, Completed, Eastern Cooperative Oncology Group; results first posted 2020-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery. Trials, record NCT00700882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00700882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
- NCT number
- NCT00700882
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Melanoma (Skin)
- Interventions
- dasatinib
- First posted
- 2008-06-19
- Last updated
- 2023-07-03
- Results first posted
- 2020-02-24
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 Among KIT-positive Patients | Every 6 weeks; up to 5 years | Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. |
| Secondary | Duration of Response for Dasatinib Monotherapy in This Patient Population | Every 6 weeks; up to 5 years | Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). |
| Secondary | Progression-free Survival | Every 6 weeks; up to 5 years | Progression-free survival is defined as the time from registration to development of progressive disease. Patients without documented progressive disease are censored at the date of last disease assessment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). |
| Other | To Evaluate the PDGFR Expression, and Activation of Src Family Kinases in Tumor Samples and Correlate These Parameters With Response to Treatment. | Every 6 weeks; up to 5 years | Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. |
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 Among KIT-positive Patients | Every 6 weeks; up to 5 years | eligible and treated KIT-positive patients | proportion of participants | NUMBER |
| SECONDARY | Duration of Response for Dasatinib Monotherapy in This Patient Population | Every 6 weeks; up to 5 years | Only eligible and treated patients with objective response (complete response or partial response) are included in this analysis. | months | MEDIAN |
| SECONDARY | Progression-free Survival | Every 6 weeks; up to 5 years | Only eligible and treated patients are included in this analysis. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | To Evaluate the PDGFR Expression, and Activation of Src Family Kinases in Tumor Samples and Correlate These Parameters With Response to Treatment. | Every 6 weeks; up to 5 years |
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 |
|---|---|---|---|---|---|
| Objective Response Rate Among KIT-positive Patients | Dasatinib | 0.182 | 90% Confidence Interval 0.104 to 0.466 | proportion of participants | |
| Duration of Response for Dasatinib Monotherapy in This Patient Population | Dasatinib | 4.2 | Full Range 0 to 17.1 | months | |
| Progression-free Survival | Dasatinib | 2.1 | 95% Confidence Interval 1.5 to 2.9 | months |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 81 | |
| Overall Study | Received Protocol Therapy | Dasatinib | 75 | |
| Overall Study | Eligible and Treated Patients | Dasatinib | 73 | |
| Overall Study | Eligible, Treated and KIT+ Patients | Dasatinib | 22 | |
| Overall Study | Eligible and Treated Patients With Objective Response | Dasatinib | 7 | |
| Overall Study | COMPLETED | Dasatinib | 22 | |
| Overall Study | NOT COMPLETED | Dasatinib | 59 |
Source ClinicalTrials.gov
Adverse events45
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 | 24 | 75 | |
| other | Edema limbs | General disorders | Dasatinib | 5 | 75 | |
| other | Fatigue | General disorders | Dasatinib | 24 | 75 | |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib | 16 | 75 | |
| other | Nausea | Gastrointestinal disorders | Dasatinib | 18 | 75 | |
| other | Vomiting | Gastrointestinal disorders | Dasatinib | 6 | 75 | |
| other | Aspartate aminotransferase increased | Investigations | Dasatinib | 8 | 75 | |
| other | Lipase increased | Investigations | Dasatinib | 4 | 75 | |
| other | Lymphocyte count decreased | Investigations | Dasatinib | 4 | 75 | |
| other | Neutrophil count decreased | Investigations | Dasatinib | 5 | 75 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | 15 | 75 |
| Total, other adverse events | Dasatinib | 54 | 75 |
| Total, serious adverse events | Dasatinib | 35 | 75 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180794 | ECOG-ACRIN Network Group Statistics and Data Management Center | CATALANO, PAUL J; GATSONIS, CONSTANTINE A. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT00700882
GET https://conductscience.org/api/trials/v1/NCT00700882/events?page=2