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NCT01092728 · ClinicalTrials.gov registry record · Phase 2
Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01092728: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01092728 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092728, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can help to control the tumor in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma. The safety of this drug will also be studied. Objectives: Primary Objectives: 1\. To compare the biological response of tumors With and Without Resectable Tumors from patients with acral, or mucosal melanomas after treatment with dasatinib. Secondary Objectives: 1. To assess the safety and tolerability of dasatinib in this patient population Completely Resectable Acral, Chronic Sun-damaged (CSD), and Mucosal Melanoma: 2. To assess the median time to recurrence and overall survival of patients with completely resectable acral, CSD, and mucosal melanoma treated with dasatinib 3. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with dasatinib predicts prolonged time to recurrence and/or overall survival in patients with completely resectable acral, CSD, and mucosal melanomas Not Completely Resectable Acral, CSD, and Mucosal Melanoma: 4. To assess the response rate, progression free survival, and overall survival of patients with acral, CSD, and mucosal melanoma treated with dasatinib 5. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with dasatinib predicts response rate, progression free survival, and/or overall survival in patients with acral, CSD, and mucosal melanomas
Primary Outcome
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
Interventions
- PROCEDURE Surgical Resection
- DRUG Dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
Why NCT01092728 stopped before completion
NCT01092728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgical Resection is the first listed.
NCT01092728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01092728 about?
NCT01092728 is a clinical study titled "Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma". The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can help to control the tumor in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma. The safety of this drug will also be studied. Objectives: Primary Objectives: 1\. To compare the biol...
What is the current status of trial NCT01092728?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2011-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01092728?
The interventions under investigation include: Surgical Resection (PROCEDURE), Dasatinib (DRUG).
Who is sponsoring clinical trial NCT01092728?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01092728's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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