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Tyrosine Kinase Inhibitor

Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

Phase 2

Waitlist Available

Led By F. Stephen Hodi, MD

Research Sponsored by Dana-Farber Cancer 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 patients were followed long-term every 3 months until first progression, death or lost to follow-up. median survival follow-up was 16.2 months (90%ci 11.7-17.7 months; no/with cns mets 16.2m/ 11.7m).

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

Given the poor prognosis and limited treatment options available for patients with mucosal or acral/lentiginous melanomas who develop metastatic disease, genetic discoveries of KIT mutations in these cancers present the need to test multi-targeted kinase inhibitors with potent KIT inhibitory activity in this patient population. Imatinib and other tyrosine kinase inhibitors (TKIs) have the potential to be effective in this patient population, but patients may develop resistance to treatment. Therefore, in this study, we propose to test nilotinib in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma following treatment with another TKI.

Eligible Conditions

Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients were followed long-term every 3 months until first progression, death or lost to follow-up. median survival follow-up was 16.2 months (90%ci 11.7-17.7 months; no/with cns mets 16.2m/ 11.7m).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients were followed long-term every 3 months until first progression, death or lost to follow-up. median survival follow-up was 16.2 months (90%ci 11.7-17.7 months; no/with cns mets 16.2m/ 11.7m).

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients were followed long-term every 3 months until first progression, death or lost to follow-up. median survival follow-up was 16.2 months (90%ci 11.7-17.7 months; no/with cns mets 16.2m/ 11.7m). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

4-month Progression-Free Survival Rate

Secondary study objectives

Best Overall Response

Overall Survival

Progression-Free Survival

Side effects data

From 2014 Phase 3 trial • 267 Patients • NCT01275196

28%

Thrombocytopenia

27%

Leukopenia

23%

Platelet count decreased

22%

Lipase increased

21%

White blood cell count decreased

19%

Nasopharyngitis

19%

Eyelid oedema

14%

Anaemia

14%

Neutropenia

14%

Diarrhoea

13%

Hypophosphataemia

13%

Rash

12%

Alanine aminotransferase increased

12%

Neutrophil count decreased

11%

Haemoglobin decreased

11%

Pyrexia

11%

Vomiting

11%

Nausea

10%

Upper respiratory tract infection

10%

Hypokalaemia

Blood creatine phosphokinase increased

Hypertriglyceridaemia

Blood phosphorus decreased

Face oedema

Aspartate aminotransferase increased

Arthralgia

Cough

Myalgia

Blood bilirubin increased

Dizziness

Influenza

Hyperglycaemia

Headache

Hyperbilirubinaemia

Abdominal pain upper

Bilirubin conjugated increased

Low density lipoprotein increased

Apolipoprotein B increased

Gamma-glutamyltransferase increased

Hypercholesterolaemia

Oesophageal squamous cell carcinoma

Ovarian rupture

Thrombocytosis

Anal abscess

Ankle fracture

Blast cell count increased

Intervertebral disc protrusion

Cervix carcinoma stage 0

Non-Hodgkin's lymphoma recurrent

Cerebral haemorrhage

Hydrothorax

Thrombocytopenic purpura

Bone marrow failure

Granulocytopenia

100%

80%

60%

40%

20%

Study treatment Arm

Imatinib 400 mg qd

Nilotinib 300 mg Bid

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NilotinibExperimental Treatment1 Intervention

Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nilotinib

FDA approved

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