Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients
NCT ID: NCT02490488
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
248 participants
INTERVENTIONAL
2014-04-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Masitinib
Gemcitabine
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.
Gemcitabine
Placebo
Interventions
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Masitinib
Gemcitabine
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy)
* First line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy);
* Candidate to third line of treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line).
2. Patient with adequate organ function per laboratory tests evaluations
Exclusion Criteria
2. Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)
3. Pregnant or nursing female patient
18 Years
FEMALE
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Julien Grenier, Dr
Role: PRINCIPAL_INVESTIGATOR
AB Science
Locations
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Centre hospitalo-universitaire de Beni Messous
Algiers, , Algeria
Institut Sainte Catherine
Avignon, , France
City Oncology Clinic
Saint Petersburg, , Russia
Complejo Hospitalario Universitario de Santiago
Santiago, , Spain
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, , Ukraine
University Hospital Coventry
Coventry, , United Kingdom
Countries
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Other Identifiers
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AB12008
Identifier Type: -
Identifier Source: org_study_id