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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
This study is currently recruiting participants.
Verified by AB Science, November 2008
Sponsored by: AB Science
Information provided by: AB Science
ClinicalTrials.gov Identifier: NCT00789633
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: masitinib
Drug: placebo
Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AB Science:

Primary Outcome Measures:
  • Overall survival [ Time Frame: until death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: November 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
masitinib in combination with gemcitabine
Drug: masitinib
9 mg/kg/day
2: Placebo Comparator
placebo in combination with gemcitabine
Drug: placebo
matching placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789633

Contacts
Contact: Gaël Deplanque, MD +33 1 44 12 30 78 gdeplanque@hpsj.fr

Locations
United States, Connecticut
Eastern Connecticut Hematology and Oncology (ECHO) Recruiting
Norwich, Connecticut, United States
United States, Massachusetts
Berkshire Hematology Oncology Recruiting
Pittsfield, Massachusetts, United States
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States
France
Hôpital Saint-Joseph Recruiting
Paris, France
Contact: , MD            
Hôpital Jean Minjoz Recruiting
Besançon, France
Hôpital Saint-André Recruiting
Bordeaux, France
Hôpital Victor Jousselin Recruiting
Dreux, France
Centre Léon Bérard Recruiting
Lyon, France
Hôpital Edouard Herriot Recruiting
Lyon, France
Hôpital Haut-Lévêque Recruiting
Pessac, France
Hôpital de la Source Recruiting
Orléans, France
CHU Henri Mondor Recruiting
Créteil, France
Hôpital Paul Brousse Recruiting
Villejuif, France
Hôpital Hôtel Dieu Recruiting
Paris, France
Centre Hospitalier de Longjumeau Recruiting
Longjumeau, France
CHU de la Cavale Blanche Recruiting
Brest, France
CHU Hôtel Dieu Recruiting
Clermont-Ferrand, France
CHD Les Oudairies Recruiting
La Roche sur Yon, France
Hôpital Claude Huriez Recruiting
Lille, France
CHU Hôtel Dieu Recruiting
Nantes, France
Hôpital André Mignot Recruiting
Versailles, France
Institut Sainte-Catherine Recruiting
Avignon, France
Hôpital Tenon Recruiting
Paris, France
Sponsors and Collaborators
AB Science
  More Information

Responsible Party: AB Science ( Alain Moussy, CEO )
Study ID Numbers: AB07012
Study First Received: November 12, 2008
Last Updated: November 27, 2008
ClinicalTrials.gov Identifier: NCT00789633  
Health Authority: United States: Food and Drug Administration;   France: Afssaps - French Health Products Safety Agency

Keywords provided by AB Science:
Pancreatic cancer
Advanced pancreatic cancer
Metastatic pancreatic cancer
Gemcitabine
Chemo-naive

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009