Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
AB Science
Study ID
NCT01280565
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Masitinib — DRUG
    Masitinib 7.5 mg/kg/day
  • Dacarbazine — DRUG
    IV bolus at 1,000 mg/m2 once every 3 weeks

Study Details

The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day 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 and who have not previously been treated for melanoma.

Key Dates

Start date
Jan 31, 2011
Status verified
Dec 2019
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019

Study Design

Enrollment
134 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib
    Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
  • Active Comparator: Dacarbazine
    Participants receive dacarbazine, given via IV bolus at 1,000 mg/m2 once every 3 weeks. Following a protocol amendment, the dacarbarzine treatment group has been closed

Primary Outcome Measure

Objective Response Rate [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Blumenthal Cancer CentreCharlotteNorth Carolina28204-

Find similar trials in Charlotte, NC

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Blumenthal Cancer Centre· Charlotte, NC

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