Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study summary:

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 not tolerate a KIT targeting tyrosine kinase inhibitor (TKI) (e.g. including but not limited to imatinib mesylate, sunitinib, or dasatanib), who are alive and without progression of disease four months after beginning treatment with nilotinib. Secondary - To determine early evidence of biologic and clinical activity by best overall response rate. - To estimate time to progression of disease and overall survival. - To determine the tolerability of nilotinib. - To evaluate the use of FDG-PET scanning in determining early biologic response to therapy. - To correlate c-kit mutational status and amplification status with response to therapy. - To evaluate the feasibility of nilotinib. - To evaluate the tolerability of nilotinib in patients with brain metastases.


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 < 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


Study is Available At:


Original ID:

08-244


NCT ID:

NCT00788775


Secondary ID:


Study Acronym:


Brief Title:

Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma


Official Title:

A Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dana-Farber Cancer Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:F. Stephen Hodi, MD
Principal Investigator
Dana-Farber Cancer Institute

Study Dates

Start Date:January 2009
Completion Date:March 2014
Completion Type:Actual
Primary Completion Date:April 2011
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:April 20, 2018
First Received Date:November 10, 2008
First Results Date:August 22, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure:4-month Progression-Free Survival Rate
Time Frame:Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued
Safety Issues:False
Description:4-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 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at l
Outcome Type:Secondary Outcome
Measure:Progression-Free Survival
Time Frame:Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every
Safety Issues:False
Description:Progression-free survival (PFS) 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 or death. Per RECIST 1.0 criteria: progressive disease (PD) is at
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Patients were followed long-term every 3 months until first progression, death or lost to follow-up.
Safety Issues:False
Description:Overall survival (OS) is defined as the time from study entry to death or date last known alive.
Outcome Type:Secondary Outcome
Measure:Best Overall Response
Time Frame:Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every
Safety Issues:False
Description: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)

Study Interventions

Intervention Type:Drug
Name:Nilotinib
Arm Name:Nilotinib
Other Name:Tasigna

Study Arms

Study Arm Type:Experimental
Arm Name:Nilotinib
Description:Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dana-Farber Cancer Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:Brigham and Women's Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Carvajal RD, Lawrence DP, Weber JS, Gajewski TF, Gonzalez R, Lutzky J, O'Day SJ, Hamid O, Wolchok JD, Chapman PB, Sullivan RJ, Teitcher JB, Ramaiya N, Giobbie-Hurder A, Antonescu CR, Heinrich MC, Bastian BC, Corless CL, Fletcher JA, Hodi FS. Phase II Study of Nilotinib in Melanoma Harboring KIT Alterations Following Progression to Prior KIT Inhibition. Clin Cancer Res. 2015 May 15;21(10):2289-96. doi: 10.1158/1078-0432.CCR-14-1630. Epub 2015 Feb 18.
PMID:25695690

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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