Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients

Sponsor
AB Science
Study ID
NCT02490488
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Masitinib — DRUG
  • Gemcitabine — DRUG
  • Placebo — DRUG

Study Details

The objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients.

Key Dates

Start date
Apr 30, 2014
Status verified
Apr 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

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

Arms

  • Experimental: Masitinib & gemcitabine
    Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine 1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion.
  • Placebo Comparator: Placebo & gemcitabine
    Participants receive placebo (6 mg/kg/day), given orally twice daily, plus gemcitabine 1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]

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