Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Part of paid clinical trials in Norwich, Connecticut.

Sponsor
AB Science
Study ID
NCT00789633
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Masitinib — DRUG
    Masitinib at 9 mg/kg/day given orally twice daily
  • Placebo — DRUG
    Matching placebo given orally twice daily
  • Gemcitabine — DRUG
    Gemcitabine at 1000 mg/m2 by intravenous infusion

Study Details

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

Key Dates

Start date
Nov 25, 2008
Status verified
Dec 2018
Primary completion
Dec 23, 2011
Completion
Aug 31, 2012

Study Design

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

Arms

  • Experimental: Masitinib & gemcitabine
    Participants receive masitinib (9 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.
  • Placebo Comparator: Placebo & gemcitabine
    Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From day of randomization to the date of death, assessed up to 60 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Eastern Connecticut Hematology and Oncology (ECHO)NorwichConnecticut06360-
MD AndersonOrlandoFlorida32806-
The Emory ClinicAtlantaGeorgia30322-
Decatur Memorial HospitalDecaturIllinois62526-
Medical & Surgical SpecialistsGalesburgIllinois61401-
Berkshire Hematology OncologyPittsfieldMassachusetts01201-
Henry Ford Health SystemDetroitMichigan48202-
Metro MN CCOPSaint Louis ParkMinnesota55416-
Saint Luke's Cancer InstituteKansas CityMissouri64111-
The Valley HospitalParamusNew Jersey07652-
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27534-
Oregon Health & Science UniversityPortlandOregon97239-

Find similar trials in Norwich, CT

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Eastern Connecticut Hematology and Oncology (ECHO)· Norwich, CTMD Anderson· Orlando, FLThe Emory Clinic· Atlanta, GADecatur Memorial Hospital· Decatur, ILMedical & Surgical Specialists· Galesburg, ILBerkshire Hematology Oncology· Pittsfield, MA

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