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Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.

NCT01168050 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-02-08

No results posted yet for this study

Summary

NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include:

* Disease control rate (complete, partial response and stable disease)
* Metabolic response
* Tolerance NCI CTCAE Version 3.0
* Biomarkers associated to response and disease control.

Conditions

  • Malignant Skin Melanoma T0
  • Stage III Melanoma
  • Stage IV Melanoma
  • Amplification

Interventions

DRUG

Nilotinib

Nilotinib 400 mg twice per day

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Celeste Lebbe, MD, PhD · Hôpital Saint-Louis, Paris, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01168050 on ClinicalTrials.gov