Trial · NCT00424515
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
NCT00424515, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2016-12-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma. Trials, record NCT00424515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
- NCT number
- NCT00424515
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Mucosal Melanoma, Acral/Lentiginous Melanoma, Chronically Sun Damaged Melanomas
- Interventions
- Imatinib
- First posted
- 2007-01-19
- Last updated
- 2016-12-08
- Results first posted
- 2016-12-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response | Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). | Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions. |
| Secondary | Time to Progression | Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). | Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
| Secondary | Overall Survival | Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1). | Overall survival (OS) is defined as the time from study entry to death or date last known alive. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response | Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). | The analysis dataset is comprised of treated patients. | participants | NUMBER |
| SECONDARY | Time to Progression | Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). | The analysis dataset is comprised of treated patients. | months | MEDIAN |
| SECONDARY | Overall Survival | Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1). | The analysis dataset is comprised of treated patients. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response | Amplified KIT | Complete Response | 0 | participants | |
| Best Overall Response | Mutated KIT | Complete Response | 0 | participants | |
| Best Overall Response | Amplified KIT | Partial Response | 0 | participants | |
| Best Overall Response | Mutated KIT | Partial Response | 7 | participants | |
| Best Overall Response | Amplified KIT | Stable Disease | 2 | participants | |
| Best Overall Response | Mutated KIT | Stable Disease | 3 | participants | |
| Best Overall Response | Amplified KIT | Progressive Disease | 9 | participants | |
| Best Overall Response | Mutated KIT | Progressive Disease | 3 | participants | |
| Time to Progression | Amplified KIT | 3.4 | 95% Confidence Interval 1.0 to 5.7 | months | |
| Time to Progression | Mutated KIT | 3.9 | 95% Confidence Interval 2.6 to 6.6 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amplified KIT | 11 | |
| Overall Study | STARTED | Mutated KIT | 13 | |
| Overall Study | COMPLETED | Amplified KIT | 0 | |
| Overall Study | COMPLETED | Mutated KIT | 0 | |
| Overall Study | NOT COMPLETED | Amplified KIT | 11 | |
| Overall Study | NOT COMPLETED | Mutated KIT | 13 |
Source ClinicalTrials.gov
Adverse events138
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 | Abdomen, pain | Gastrointestinal disorders | Amplified KIT | 0 | 11 | |
| other | Abdomen, pain | Gastrointestinal disorders | Mutated KIT | 2 | 13 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Amplified KIT | 0 | 11 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Mutated KIT | 1 | 13 | |
| other | ALT, SGPT | Investigations | Amplified KIT | 0 | 11 | |
| other | ALT, SGPT | Investigations | Mutated KIT | 2 | 13 | |
| other | Anorexia | Metabolism and nutrition disorders | Amplified KIT | 3 | 11 | |
| other | Anorexia | Metabolism and nutrition disorders | Mutated KIT | 2 | 13 | |
| other | AST, SGOT | Investigations | Amplified KIT | 0 | 11 | |
| other | AST, SGOT | Investigations | Mutated KIT | 3 | 13 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amplified KIT | ||
| Total, all-cause mortality | Mutated KIT | ||
| Total, other adverse events | Amplified KIT | 9 | 11 |
| Total, other adverse events | Mutated KIT | 13 | 13 |
| Total, serious adverse events | Amplified KIT | 1 | 11 |
| Total, serious adverse events | Mutated KIT | 3 | 13 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Amplified KIT vs Mutated KIT: 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/NCT00424515
GET https://conductscience.org/api/trials/v1/NCT00424515/events?page=2