- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099514
Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).
Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Samsung Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
- Documented KIT aberration
Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥ 1500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
- Serum calcium ≤ 12.0 mg/dL
- Serum creatinine ≤ 1.5 x ULN
- Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
- May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
- At least one measurable lesion by RECIST criteria
- ECOG PS 0-2
Exclusion Criteria:
- Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
- QTc > 470 msec on baseline EKG.
- Pregnancy or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nilotinib
Nilotinib 400 mg (2 capsules) PO BID q 28 days
|
D1~ Nilotinib 400 mg (2 capsules) PO BID q 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: 1~2 year
|
1~2 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-02-026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Melanoma With KIT Aberration
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Guangxi Medical UniversityCompletedFull Gene Sequences of c-KIT、PDGFRA and DOG1 Are Analyzed With the Screening-sequencing Approach | Investigate the Characteristics and Variations Associated With the Different Gene Mutations of c-KIT、PDGFRA and DOG1 in GIST Patients
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMetastatic Melanoma | Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Unresectable Melanoma | C-KIT Tyrosine Kinase Protein Overexpression | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Metastatic Gastrointestinal Stromal Tumor | Pathologic Stage IV Cutaneous Melanoma... and other conditionsUnited States
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Daiichi Sankyo, Inc.PlexxikonTerminatedV600-mutated BRAF Unresectable Melanoma | V600-mutated BRAF Metastatic Melanoma | Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF InhibitorUnited States, Germany, France
-
Mohammed M MilhemGenentech, Inc.TerminatedMelanoma | Metastatic Melanoma | BRAF-mutated Metastatic Melanoma | V600EBRAF-mutated Metastatic MelanomaUnited States
-
National Cancer Institute (NCI)TerminatedMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
Delcath Systems Inc.Active, not recruitingMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
MorphotekTerminatedMelanoma | Metastatic Melanoma | Advanced Melanoma | Malignant Metastatic MelanomaUnited States
-
GlaxoSmithKlineWithdrawnCancer | Metastatic Uveal Melanoma | GNA11 Mutation-positive Metastatic Melanoma | GNAQ Mutation-positive Metastatic Melanoma
-
Elizabeth DavisBristol-Myers SquibbTerminatedMetastatic Melanoma | Advanced Melanoma | Metastatic Melanoma Stratified by MHC-II ExpressionUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMetastatic Melanoma | Metastatic Uveal Melanoma | Unresectable Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | Pathologic Stage III Cutaneous... and other conditionsUnited States
Clinical Trials on Nilotinib
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Niguarda HospitalCompletedLeukemia, Myeloid, Chronic-PhaseItaly
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Novartis PharmaceuticalsTerminatedPulmonary Arterial HypertensionSwitzerland, United States, Germany, Singapore, Korea, Republic of, Canada
-
Georgetown UniversityUnknownParkinson Disease | Parkinsons Disease With DementiaUnited States
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XSpray MicroparticlesCompleted
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Shenzhen Second People's HospitalDongguan People's Hospital; Zhongshan People's Hospital, Guangdong, China; The... and other collaboratorsRecruitingChronic Myeloid Leukemia, Chronic Phase | NilotinibChina
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Andrew J. Wagner, MD, PhDMassachusetts General Hospital; Novartis; Brigham and Women's HospitalActive, not recruitingTenosynovial Giant Cell Tumor | Pigmented Villonodular Synovitis | Diffuse-type Giant Cell TumorUnited States
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Novartis PharmaceuticalsNo longer availableHypereosinophilic Syndrome (HES)
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KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals Industries...Not yet recruiting
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Novartis PharmaceuticalsNo longer availableAcute Lymphoblastic Leukemia (ALL)
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Novartis PharmaceuticalsCompleted