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

NCT01168050 | Unknown Phase 2 DMC

• 1 other identifier: P081237
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malignant Skin Melanoma T0; stage III unresectable melanomas,; or stage IV melanomas with c-KIT mutation; or amplification.

Outcome Measures

Primary Outcomes (1)

• Objective response

  Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST).

  6 months

Secondary Outcomes (4)

• Disease control

  6 months

• Objective response

  3 months

• Metabolic response

  6 months

• Tolerance

  1 year

Study Arms (1)

Nilotinib

EXPERIMENTAL

Drug: Nilotinib

Interventions

Nilotinib DRUG

Nilotinib 400 mg twice per day

Nilotinib

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven melanoma with either c-KIT mutation or C-KIT amplification (without BRAF or NRAS mutation)
• Unresectable primary or stage III or stage IV melanoma
• Measurable disease (RECIST)
• No more than 1 previous specific therapy excluding tyrosine kinase inhibitors. 4 weeks wash out will be needed after cytotoxic therapy , 12 weeks wash out after anti -CTLA4 therapy or any immunological treatment
• ECOG performance status \< 2
• WBC ≥ 3,000/mm³
• PNN ≥ 1,500/mm³ (G-CSF allowed)
• platelets ≥ 100,000/mm³
• Hb ≥ 9.0 g/dL ( transfusions allowed as well as recombinant erythropoetin)
• Creatinin clearance \> 40ml/mn
• Normal kalemia
• Normal magnesemia
• Total bilirubin \<1.5N ; ASAT and ALAT \<2.5N
• PT/INR and PTT normal
• NYHA class \< 3

You may not qualify if:

• Patients refusal
• Age \< 18 years
• Fertile women who do not want or cannot use effective contraception during the study and up to 8 weeks after the end of study
• Women pregnant or nursing
• Fertile and sexually active men whose partner are fertile women who do not use effective contraception
• Clinical and/or radiographic evidence of active cerebral metastases
• Severe evolutive infection
• Known HIV infection
• Concomitant therapy with any other anti-cancer, immunomodulator or immunosuppressing agent or radiotherapy (except palliative care if bone metastases, after acceptance of principal investigator).
• Previous use of tyrosine kinase inhibitors
• More than one line of prior systemic therapies of melanoma by anti-cancer agent or immunotherapy.
• Pace-maker
• Cardiac dysfunction, as evaluated by one of:
• Congenital prolonged QT
• QTc \> 450 ms

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Celeste Lebbe, MD, PhD

  Hôpital Saint-Louis, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zakia Idir, PhD

CONTACT

+33 1 4484 1747; zakia.idir@sls.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

FR (1)