A Phase 3 Study to Compare Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Placebo in Combination With Gemcitabine, in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Tracking Information
First Submitted Date ICMJE	November 12, 2008
First Posted Date ICMJE	November 13, 2008
Last Update Posted Date	September 26, 2012
Study Start Date ICMJE	November 2008
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 12, 2008)	Overall survival [ Time Frame: until death ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00789633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 12, 2008)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Phase 3 Study to Compare Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Placebo in Combination With Gemcitabine, in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Official Title ICMJE	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
Brief 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.
Detailed 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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Pancreatic Cancer
Intervention ICMJE	Drug: masitinib (AB1010) 9 mg/kg/day Other Name: AB1010; Drug: placebo matching placebo
Study Arms	Experimental: 1 masitinib (AB1010) in combination with gemcitabine Intervention: Drug: masitinib (AB1010); Placebo Comparator: 2 placebo in combination with gemcitabine Intervention: Drug: placebo
Publications *	Chugh R, Griffith KA, Davis EJ, Thomas DG, Zavala JD, Metko G, Brockstein B, Undevia SD, Stadler WM, Schuetze SM. Doxorubicin plus the IGF-1R antibody cixutumumab in soft tissue sarcoma: a phase I study using the TITE-CRM model. Ann Oncol. 2015 Jul;26(7):1459-64. doi: 10.1093/annonc/mdv171. Epub 2015 Apr 9.; Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moyé L, Piquemal D, Ritter D, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Hammel P. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Ann Oncol. 2015 Jun;26(6):1194-200. doi: 10.1093/annonc/mdv133. Epub 2015 Apr 9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: November 12, 2008)	320
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2013
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Main Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas; Chemo naïve patients with advanced/metastatic disease; Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.; Men and women, age >18 years; 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.; Patient should be able and willing to comply with study visits and procedures as per protocol.; 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: 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; 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; Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline; Treatment with any investigational agent within 4 weeks prior to baseline
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Czech Republic, France, Lebanon, Romania, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00789633
Other Study ID Numbers ICMJE	AB07012
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	AB Science
Study Sponsor ICMJE	AB Science
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Gaël Deplanque, MD Hôpital Saint Joseph, Paris, France
PRS Account	AB Science
Verification Date	September 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP