A Phase 3 interventional study of Masitinib and Placebo in Pancreatic Cancer, sponsored by AB Science. Completed at 68 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by AB Science · Phase 3, Interventional, and Treatment
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 353 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →AB Science is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Main Inclusion Criteria:
Main Exclusion Criteria:
Participants receive masitinib (9 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.
Drug: Masitinib · Drug: Gemcitabine
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.
Drug: Placebo · Drug: Gemcitabine
Masitinib at 9 mg/kg/day given orally twice daily
Also known as: AB1010
Matching placebo given orally twice daily
Gemcitabine at 1000 mg/m2 by intravenous infusion
Also known as: Gemzar
Overall Survival (OS)
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.
Time frame: From day of randomization to the date of death, assessed up to 60 months
Survival rate
Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.
Time frame: Every 24 weeks, assessed up to 60 months
Progression Free Survival (PFS)
Progression Free Survival 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.
Time frame: From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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