Status:
COMPLETED
Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Mucosal Lentiginous Melanoma
Acral Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Given the poor prognosis and limited treatment options available for patients with mucosal or acral/lentiginous melanomas who develop metastatic disease, genetic discoveries of KIT mutations in these ...
Detailed Description
OBJECTIVES: Primary \* To estimate the proportion of patients, with metastatic mucosal, acral, or chronically sun damaged melanomas, whose tumors have KIT aberrations, and who progressed or could no...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Histologically documented diagnosis of mucosal melanoma or acral melanoma or chronically sun damaged melanoma as evidenced by solar elastosis on pathology
- Patient's tumor with evidence for KIT mutation or amplification. Patient tumors that already have documented mutations or amplification do not have to have tissue submitted again for analysis to confirm eligibility
- Have failed, progressed, or not been able to tolerate other tyrosine kinase inhibitors including but not limited to imatinib mesylate, sunitinib or dasatinib treatment.
- At least one measurable site of disease
- ECOG Performance Status 0, 1 or 2
- Adequate organ function as outlined in the protocol
- Negative pregnancy test for female patients of childbearing potential
Exclusion
- Patient has received any other investigational agents within 28 days of first day of study drug dosing unless the disease is rapidly progressing
- Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
- Female patients who are pregnant or breast-feeding
- Patient has a severe and/or uncontrolled medical disease
- Patient has a rare hereditary problem of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption
- Patient with electrolyte abnormality unless the level can be corrected to normal levels prior to initiating study drug
- Known brain metastasis
- Known chronic liver disease
- Patient has received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing (6 weeks for nitrosourea or mitomycin-C)
- Patient previously received radiotherapy to 25% or greater of the bone marrow
- Patient had a major surgery within 2 weeks prior to study entry
- Impaired cardiac function
- QTc \> 450msec on screening ECG
- Myocardial infarction within one year prior to starting nilotinib
- Other clinically significant heart disease
- Patients who are currently receiving treatment with any of the medications that have the potential to prolong QT interval
- Patients who are currently receiving Warfarin \> 1mg/day
- Patient with any significant history of non-compliance to medical regimens or with the inability to grant reliable informed consent
- Prior therapy with nilotinib
Key Trial Info
Start Date :
January 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00788775
Start Date
January 23 2009
End Date
March 1 2014
Last Update
November 15 2018
Active Locations (8)
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1
The Angeles Clinic and Research Institute
Santa Monica, California, United States, 90404
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
University of Chicago
Chicago, Illinois, United States, 60637