Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Part of paid clinical trials in Orlando, Florida.

Sponsor
AB Science
Study ID
NCT00812240
Phase
PHASE3
Status
Terminated

Conditions

  • Gastrointestinal Stromal Tumors

Eligibility Criteria

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

Interventions

  • Masitinib — DRUG
  • Imatinib — DRUG
    imatinib 400 mg or 600 mg per day, per os

Study Details

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Key Dates

Start date
Jan 31, 2009
Status verified
Dec 2019
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018

Study Design

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

Arms

  • Experimental: Masitinib (7.5)
    Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
  • Experimental: Masitinib (6.0)
    Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
  • Active Comparator: Active Comparator (7.5)
    Participants receive imatinib at 400 or 600 mg per day
  • Active Comparator: Active Comparator (6.0)
    Participants receive imatinib at 400 or 600 mg per day

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months] ]

Locations (7)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterOrlandoFlorida32806-
The Emory ClinicAtlantaGeorgia30322-
Henry Ford Health SystemDetroitMichigan48202-
Beth Israel Medical CenterNew YorkNew York10003-
Ohio State UniversityColumbusOhio43210-
Cancer Centers of the CarolinasGreenvilleSouth Carolina290605-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Orlando, FL

By research site
MD Anderson Cancer Center· Orlando, FLThe Emory Clinic· Atlanta, GAHenry Ford Health System· Detroit, MIBeth Israel Medical Center· New York, NYOhio State University· Columbus, OHCancer Centers of the Carolinas· Greenville, SC

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