Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

NCT01099514 | Completed Phase 2

• 1 other identifier: 2009-02-026
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma With KIT Aberration

Outcome Measures

Primary Outcomes (1)

• response rate

  1~2 year

Study Arms (1)

Nilotinib

EXPERIMENTAL

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

Drug: Nilotinib

Interventions

Nilotinib DRUG

D1\~ Nilotinib 400 mg (2 capsules) PO BID q 28 days

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Cancer Center

Seoul, South Korea

Location

MeSH Terms

Interventions

nilotinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung medical center

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 7, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

KR (1)