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A Prospective, Multicenter, Randomized, Open-label, Activecontrolled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Dacarbazine in the Treatment of Patients With Non-resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-kit


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

Thank you

Trial Information

A Prospective, Multicenter, Randomized, Open-label, Activecontrolled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Dacarbazine in the Treatment of Patients With Non-resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-kit


Inclusion Criteria:



- Patient with histologically or cytologically confirmed non-resectable or metastatic
stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4
melanoma

- Patient with detectable c-kit JM mutation confirmed by DNA or RNA sequencing, which
is expected to be mainly found after screening of mucosal or acral melanoma or
melanoma on skin with chronic sun-induced damages (defined by a microscopically
marked elastosis involving the skin surrounding their primary melanoma)

- Patient with measurable disease according to RECIST

- Patient with ECOG ≤ 2

Exclusion Criteria:

- Patient with other malignancies from which the patient has been continuously
disease-free for < 3 years, with the exception of melanoma, cervical carcinoma in
situ, basal cell or squamous cell skin cancer, ductal or lobular carcinoma in situ of
the breast

- Patient with active brain metastases are not eligible. Patients with treated brain
metastases are eligible if :

- presence of 3 brain lesions or less

- lesion(s) diameter is ≤ 2 cm

- radiation therapy (gamma knife) was completed ≥ 4 weeks prior to baseline

- surgery was completed ≥4 weeks prior to baseline

- lesions assessed by follow-up scan (or MRI if MRI performed before brain
therapy) ≥ 1 month after brain therapy are considered under control at baseline

- Patient refractory to dacarbazine defined as patient presenting a disease progression
after 3 months of dacarbazine therapy.

- Prior treatment with a tyrosine kinase c-kit inhibitor

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Progression Free Survival (PFS)

Outcome Time Frame:

at week 6, 12, 18, 24 and every 12 weeks until progression or death

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AB08026

NCT ID:

NCT01280565

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Metastatic Melanoma
  • non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit
  • Melanoma

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