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The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.
Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine with respect to placebo in combination with gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic cancer patients with pain related to the disease. Approximately 330 patients with pain Visual Analogue Scale (VAS) > 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively. The primary outcome measure is overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masitinib & gemcitabine | Experimental | 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. |
|
| Placebo & gemcitabine | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masitinib | Drug |
|
| |
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (median) | Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive. | From day of randomization to death, assessed for a maximum of 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates | The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution | every 24 weeks |
| Progression Free Survival | Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria |
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Main inclusion criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
Patient with pain related to the disease, as assessed by the investigator and the patient:
OR
- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
3. Chemotherapy naïve patient for the advanced/metastatic disease
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joël Ezenfis, MD | Centre Hospitalier de Longjumeau, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital AZ Sint-Jan | Bruges | 8000 | Belgium | |||
| Polyclinique de Limoges site CHENIEUX |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C526575 | masitinib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
|
|
| Placebo | Drug |
|
|
| From day of randomization to disease progression or death, assessed for a maximum of 60 months |
| Limoges |
| 87000 |
| France |
| Centre Hospitalier de Longjumeau | Longjumeau | 91160 | France |
| General University Hospital of Patras | Pátrai | 26504 | Greece |
| Sanjeevani CBCC USA Cancer Hospital | Raipur | 492001 | India |
| Omsk Clinical oncology dispensary Omsk | Omsk | 644013 | Russia |
| National Oncology Institute | Bratislava | 833 10 | Slovakia |
| Institut Salah Azaiez de Cancerologie | Bab Saadoun | Tunisia |
| Center of Surgical Innovations | Kiev | Ukraine |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |