Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01099514
First received: April 6, 2010
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Melanoma With KIT Aberration
Drug: Nilotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • response rate [ Time Frame: 1~2 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Nilotinib
Nilotinib 400 mg (2 capsules) PO BID q 28 days
Drug: Nilotinib
D1~ Nilotinib 400 mg (2 capsules) PO BID q 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099514

Locations
Korea, Republic of
Samsung Cancer Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jeeyun Lee, Samsung medical center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01099514     History of Changes
Other Study ID Numbers: 2009-02-026
Study First Received: April 6, 2010
Last Updated: May 13, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 30, 2014