Trial · NCT00577382
SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
NCT00577382, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2016-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma. Trials, record NCT00577382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00577382
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
- NCT number
- NCT00577382
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
- Interventions
- Sunitinib
- First posted
- 2007-12-20
- Last updated
- 2016-12-08
- Results first posted
- 2016-12-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-month Progression-free Survival Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months. | 2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. 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 | Best Overall Response Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles. | The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new 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 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m). | Overall survival (OS) is defined as the time from study entry to death or date last known alive. |
| Secondary | Time to Progression | Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles). | Time to progression 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. |
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 | 2-month Progression-free Survival Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months. | The analysis dataset is comprised of treated patients. | proportion of patients | NUMBER |
| SECONDARY | Best Overall Response Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles. | The analysis dataset is comprised of treated patients. | proportion of participants | NUMBER |
| 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 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m). | The analysis dataset is comprised of treated patients. | months | MEDIAN |
| SECONDARY | Time to Progression | Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles). | The analysis dataset is comprised of treated patients. The majority of patients were off-treatment due to disease progression and thus the relevant observation time frame for this outcome is time on treatment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 2-month Progression-free Survival Rate | Cohort A-Sunitinib Intermittent Dosing | .52 | 95% Confidence Interval .30 to .74 | proportion of patients | |
| 2-month Progression-free Survival Rate | Cohort B-Sunitinib Continuous Dosing | .52 | 95% Confidence Interval .33 to .70 | proportion of patients | |
| Best Overall Response Rate | Cohort A-Sunitinib Intermittent Dosing | 0.095 | 95% Confidence Interval 0.012 to 0.304 | proportion of participants | |
| Best Overall Response Rate | Cohort B-Sunitinib Continuous Dosing | 0.065 | 95% Confidence Interval 0.0078 to 0.214 | proportion of participants | |
| Overall Survival | Cohort A-Sunitinib Intermittent Dosing | 7.7 | 95% Confidence Interval 6.9 to 14.9 | months | |
| Overall Survival | Cohort B-Sunitinib Continuous Dosing | 6.8 | 95% Confidence Interval 5.2 to 9.6 | months | |
| Time to Progression | Cohort A-Sunitinib Intermittent Dosing | 2.7 | 95% Confidence Interval 1.7 to 4.1 | months | |
| Time to Progression | Cohort B-Sunitinib Continuous Dosing | 3.6 | 95% Confidence Interval 1.7 to 3.9 | months |
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 | Cohort A-Sunitinib Intermittent Dosing | 21 | |
| Overall Study | STARTED | Cohort B-Sunitinib Continuous Dosing | 31 | |
| Overall Study | COMPLETED | Cohort A-Sunitinib Intermittent Dosing | 0 | |
| Overall Study | COMPLETED | Cohort B-Sunitinib Continuous Dosing | 0 | |
| Overall Study | NOT COMPLETED | Cohort A-Sunitinib Intermittent Dosing | 21 | |
| Overall Study | NOT COMPLETED | Cohort B-Sunitinib Continuous Dosing | 31 |
Source ClinicalTrials.gov
Adverse events234
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 | Cohort A-Sunitinib Intermittent Dosing | 1 | 21 | |
| other | Abdomen, pain | Gastrointestinal disorders | Cohort B-Sunitinib Continuous Dosing | 0 | 31 | |
| other | Alkaline phosphatase | Investigations | Cohort A-Sunitinib Intermittent Dosing | 1 | 21 | |
| other | Alkaline phosphatase | Investigations | Cohort B-Sunitinib Continuous Dosing | 2 | 31 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort A-Sunitinib Intermittent Dosing | 2 | 21 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort B-Sunitinib Continuous Dosing | 0 | 31 | |
| other | ALT, SGPT | Investigations | Cohort A-Sunitinib Intermittent Dosing | 2 | 21 | |
| other | ALT, SGPT | Investigations | Cohort B-Sunitinib Continuous Dosing | 3 | 31 | |
| other | Amylase | Investigations | Cohort A-Sunitinib Intermittent Dosing | 3 | 21 | |
| other | Amylase | Investigations | Cohort B-Sunitinib Continuous Dosing | 3 | 31 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A-Sunitinib Intermittent Dosing | ||
| Total, all-cause mortality | Cohort B-Sunitinib Continuous Dosing | ||
| Total, other adverse events | Cohort A-Sunitinib Intermittent Dosing | 19 | 21 |
| Total, other adverse events | Cohort B-Sunitinib Continuous Dosing | 24 | 31 |
| Total, serious adverse events | Cohort A-Sunitinib Intermittent Dosing | 10 | 21 |
| Total, serious adverse events | Cohort B-Sunitinib Continuous Dosing | 13 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26264378 | RESULT |
Source PubMed
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 |
|---|
| Cohort A-Sunitinib Intermittent Dosing vs Cohort B-Sunitinib Continuous Dosing: 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/NCT00577382
GET https://conductscience.org/api/trials/v1/NCT00577382/events?page=2