Masitinib Plus Gemcitabine in Pancreatic Cancer

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Gemcitabine

Criteria

Main inclusion criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage

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

Main exclusion criteria:

1. Patient with no pain related to the disease (as defined in the inclusion criterion number 2)

2. Pregnant or nursing female patient