Phase 2
N=20
Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma
Mucosal Lentiginous Melanoma · Acral Melanoma · Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00788775 ↗Enrolled (actual)
20
Serious AEs
21.1%
Results posted
Dec 2016
Primary outcome: Primary: 4-month Progression-Free Survival Rate — 0.27; 0.125 proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nilotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 4-month Progression-Free Survival Rate |
0.27; 0.125 | — |
| SECONDARY Progression-Free Survival |
3.4; 2.4 | — |
| SECONDARY Overall Survival |
14.2; 4.3 | — |
| SECONDARY Best Overall Response |
0; 0; 2; 0; 4; 6 | — |
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 cancers present the need to test multi-targeted kinase inhibitors with potent KIT inhibitory activity in this patient population. Imatinib and other tyrosine kinase inhibitors (TKIs) have the potential to be effective in this patient population, but patients may develop resistance to treatment. Therefore, in this study, we propose to test nilotinib in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma following treatment with another TKI.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00788775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.