Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments masitinib (ab1010), placebo
Phase phase 3
Sponsor AB Science
Start date November 2008
End date December 2011
Trial size 320 participants
Trial identifier NCT00789633, AB07012

Summary

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
masitinib (AB1010) in combination with gemcitabine
masitinib (ab1010) AB1010
9 mg/kg/day
(Placebo Comparator)
placebo in combination with gemcitabine
placebo
matching placebo

Primary Outcomes

Measure
Overall survival
time frame: until death

Secondary Outcomes

Measure
Survival rate, Objective Response Rate, Control Disease Rate, Best Response, Serum level of CA19-9. Progression Free Survival, Time to Progression, Time to Response, Quality of Life questionnaires, Pain and analgesics consumption.
time frame: until death

Eligibility Criteria

Male or female participants at least 18 years old.

Main 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. Men and women, age >18 years 5. 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. 6. Patient should be able and willing to comply with study visits and procedures as per protocol. 7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Main 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. 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 3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline 4. Treatment with any investigational agent within 4 weeks prior to baseline

Additional Information

Official title A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Principal investigator Gaël Deplanque, MD
Description Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by AB Science.