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Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Primary Purpose

Metastatic Melanoma With KIT Aberration

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nilotinib
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma With KIT Aberration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
  2. Documented KIT aberration

  3. 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
  4. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
  5. May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
  6. At least one measurable lesion by RECIST criteria
  7. ECOG PS 0-2

Exclusion Criteria:

  1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
  2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
  3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
  4. QTc > 470 msec on baseline EKG.
  5. Pregnancy or breastfeeding.

Sites / Locations

  • Samsung Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nilotinib

Arm Description

Nilotinib 400 mg (2 capsules) PO BID q 28 days

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

Full Information

First Posted
April 6, 2010
Last Updated
December 28, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01099514
Brief Title
Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Official Title
Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma With KIT Aberration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib
Arm Type
Experimental
Arm Description
Nilotinib 400 mg (2 capsules) PO BID q 28 days
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Intervention Description
D1~ Nilotinib 400 mg (2 capsules) PO BID q 28 days
Primary Outcome Measure Information:
Title
response rate
Time Frame
1~2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Samsung Cancer Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

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