A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, Phase III study to compare efficacy and safety of masitinib at 9 mg/kg/day in combination with gemcitabine, to placebo in combination with gemcitabine, in treatment of patients with advanced/metastatic pancreatic cancer

Conditions: advanced/metastatic pancreatic cancer
MedDRA version: 9.1Level: LLTClassification code 10033610Term: Pancreatic carcinoma metastatic

Registration Number: EUCTR2008-000974-18-HU

Lead Sponsor: AB SCIENCE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 320

Inclusion Criteria

1.Histologically or cytologically confirmed adenocarcinoma of the pancreas
2.Chemo naïve patients with advanced/metastatic disease
3.Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
4.Measurable tumor lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according RECIST criteria
5.ECOG = 1
6.Patient with organ function as follows:
•absolute neutrophil count (ANC) = 1.5 x 109/L
•haemoglobin = 10 g/dL
•platelets (PTL) = 100 x 109/L
•AST/ALT = 2.5x ULN (= 5 x ULN in case of liver metastases)
•bilirubin = 1.5x ULN
•creatinin clearance = 50 mL/min (Cockcroft and Gault formula)
•albumin > 0.75 x LLN
•urea = 2 x ULN
•proteinuria < 30 mg/dL; in case of proteinuria = 30 mg/dL, 24-hour proteinuria should be < 1.5g/24 hours
7.Patient with life expectancy > 12 weeks
8.Men and women, age >18 years
9.Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
10.Patient should be able and willing to comply with study visits and procedures as per protocol.
11.Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer
2.Patient with, or with history, of CNS metastasis
3.Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline)
4.Patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
5.History of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or give informed consent
6.Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events
?Previous treatment
7.Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
8.Treatment with any investigational agent within 4 weeks prior to baseline

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to compare efficacy and safety of masitinib at 9 mg/kg/day in combination with gemcitabine, to placebo in combination with gemcitabine, in treatment of patients with advanced/metastatic pancreatic cancer.;Secondary Objective: •Tumor assessment:<br>oOS rate at week 24, 48 and 72<br>oProgression Free Survival (PFS). <br>oTime to Progression (TTP)<br>oObjective response rate (CR + PR) at week 24, 48 and 72<br>oControl disease rate (CR + PR + SD) at week 24, 48 and 72<br>oBest response at week 24, 48 and 72<br>oTime to response<br>oLevel of serum CA 19-9 at week 24, 48 and 72<br>•Quality of life assessment:<br>oQuality of Life according to the EORTC QLQ-C30 questionnaire at time point<br>oECOG Performance Status at time point<br>oPatient’s visual analog scale (VAS) of pain at time point<br>oAnalgesic consumption at time point<br>•Safety profile using the NCI CTC v3.0 classification<br>;Primary end point(s): Overall survival (OS). Last patient followed until week

Secondary Outcome Measures