Trials / Completed
CompletedNCT03766295
Masitinib Plus Gemcitabine in Pancreatic Cancer
A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 377 (actual)
- Sponsor
- AB Science · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Masitinib | |
| DRUG | Gemcitabine | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2018-12-06
- Last updated
- 2020-12-08
Locations
9 sites across 8 countries: Belgium, France, Greece, India, Russia, Slovakia, Tunisia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03766295. Inclusion in this directory is not an endorsement.