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
PHASE3
377 participants
INTERVENTIONAL
2014-07-31
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
DOUBLE
Study Groups
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Masitinib & gemcitabine
Participants receive masitinib (6 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.
Masitinib
Gemcitabine
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.
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
2. Patient with pain related to the disease, as assessed by the investigator and the patient:
* Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
* Pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).
OR
\- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
3\. Chemotherapy naïve patient for the advanced/metastatic disease
Exclusion Criteria
2. Pregnant or nursing female patient
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Joël Ezenfis, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de Longjumeau, France
Locations
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Hospital AZ Sint-Jan
Bruges, , Belgium
Polyclinique de Limoges site CHENIEUX
Limoges, , France
Centre Hospitalier de Longjumeau
Longjumeau, , France
General University Hospital of Patras
Pátrai, , Greece
Sanjeevani CBCC USA Cancer Hospital
Raipur, , India
Omsk Clinical oncology dispensary Omsk
Omsk, , Russia
National Oncology Institute
Bratislava, , Slovakia
Institut Salah Azaiez de Cancerologie
Bab Saadoun, , Tunisia
Center of Surgical Innovations
Kiev, , Ukraine
Countries
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Other Identifiers
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AB12005
Identifier Type: -
Identifier Source: org_study_id