Status:
COMPLETED
A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use ...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years of age.
- Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
- Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
- At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
- Performance status 0,1, 2 or 3 (ECOG).
- Adequate end organ function.
- Adequate bone marrow function.
- Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
Exclusion
- Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Other primary malignancy with \< 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- Pregnancy, breast-feeding.
- Severe and/or uncontrolled medical disease.
- Known brain metastasis.
- Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
- Previous radiotherapy to ≥ 25 % of the bone marrow.
- Major surgery within 2 weeks prior to study entry.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00940563
Start Date
March 1 2002
Last Update
July 1 2011
Active Locations (26)
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1
Novartis Investigative Site
Ancona, Italy
2
Novartis Investigative Site
Aviano, Italy
3
Novartis Investigative Site
Bari, Italy
4
Novartis Investigative Site
Bergamo, Italy