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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by AB Science.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
AB Science Identifier:
First received: November 12, 2008
Last updated: September 25, 2012
Last verified: September 2012
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 (AB1010)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AB Science:

Primary Outcome Measures:
  • Overall survival [ Time Frame: until death ]

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 ]

Estimated Enrollment: 320
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
masitinib (AB1010) in combination with gemcitabine
Drug: masitinib (AB1010)
9 mg/kg/day
Other Name: AB1010
Placebo Comparator: 2
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00789633

  Show 68 Study Locations
Sponsors and Collaborators
AB Science
Principal Investigator: Gaël Deplanque, MD Hôpital Saint Joseph, Paris, France
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AB Science Identifier: NCT00789633     History of Changes
Other Study ID Numbers: AB07012
Study First Received: November 12, 2008
Last Updated: September 25, 2012

Keywords provided by AB Science:
Pancreatic cancer
Advanced pancreatic cancer
Metastatic pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017