Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

until death

Safety Issue:

No

Principal Investigator

Gaël Deplanque, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Saint Joseph, Paris, France

Authority:

United States: Food and Drug Administration

Study ID:

AB07012

NCT ID:

NCT00789633

Start Date:

November 2008

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • Advanced pancreatic cancer
  • Metastatic pancreatic cancer
  • Gemcitabine
  • Chemo-naive
  • Pancreatic Neoplasms

Name

Location

Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Oregon Health & Science UniversityPortland, Oregon  97201
Henry Ford Health SystemDetroit, Michigan  48202
Decatur Memorial HospitalDecatur, Illinois  62526
The Emory ClinicAtlanta, Georgia  30322
Berkshire Hematology OncologyPittsfield, Massachusetts  01201
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Medical & Surgical SpecialistsGalesburg, Illinois  61401
MD AndersonOrlando, Florida  32806
The Valley HospitalParamus, New Jersey  07652
Metro MN CCOPMinneapolis, Minnesota  55416
Eastern Connecticut Hematology and Oncology (ECHO)Norwich, Connecticut  06360