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Tyrosine Kinase Inhibitor

Suntinib for Melanoma

Phase 2
Waitlist Available
Led By David R Minor, MD
Research Sponsored by California Pacific Medical Center Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations. KIT is a gene that "codes for" (contains the genetic code that the body uses to make) a protein on the surface of cells in your body that is important in cell growth and cell division. The KIT protein seems to play a role in abnormal cell growth seen in acute leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas. Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and chronically sun damaged skin have recently been found to frequently contain mutations or increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has been found to contain abnormalities in the KIT gene. Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib malate works in these patients because of its activity against the KIT protein. The FDA also approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its effectiveness is probably due to its ability to block a different set of proteins. Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the objective response rate of metastatic melanoma patients with KIT aberrations to therapy with sunitinib.
Secondary outcome measures
Study the safety and toxicity of sunitinib when given to metastatic melanoma patients with KIT aberrations.

Side effects data

From 2017 Phase 2 & 3 trial • 78 Patients • NCT01164202
31%
Platelets
28%
Neutrophiles
26%
Bilirubine
23%
Asthenia
21%
ASAT
21%
ALAT
15%
Leucocytose
13%
Hand-foot syndrome
13%
Liver failure
10%
Abdominal pain
8%
Anorexia
8%
Fever
8%
Increase GGT
5%
Arterial hypertension
5%
Diarrhea
5%
Encephalopathy
5%
Ascite
5%
Phosphatases alcalines
5%
Liver pain
5%
Encephalopathia
5%
Hemoglobine
3%
Hemoglobin
3%
Lumbar pain
3%
Prothrombin time
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sunitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: SuntinibExperimental Treatment1 Intervention
Suntinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib
FDA approved

Find a Location

Who is running the clinical trial?

California Pacific Medical Center Research InstituteLead Sponsor
43 Previous Clinical Trials
12,514 Total Patients Enrolled
5 Trials studying Melanoma
146 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,580 Previous Clinical Trials
14,635,228 Total Patients Enrolled
51 Trials studying Melanoma
49,425 Patients Enrolled for Melanoma
University of California, San FranciscoOTHER
2,515 Previous Clinical Trials
15,240,420 Total Patients Enrolled
11 Trials studying Melanoma
381 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby May 2025