Status:
COMPLETED
A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year ex...
Eligibility Criteria
Inclusion
- Men and non-pregnant women ≥18 years of age with the histopathologically documented diagnosis of malignant GIST that was unresectable and/or metastatic. Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample was also required
- At least one measurable lesion, as defined by Southwestern Oncology Group (SWOG) Solid Tumor Response Criteria, which had not been previously embolized or irradiated
- Performance status ≤3 as defined by the Eastern Cooperative Oncology Group (ECOG) criteria, as well as a life expectancy ≥6 months and adequate end organ function defined as follows: Total bilirubin \<1.5 times upper limit of normal (ULN), aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) \<2.5 x ULN (or \<5 x ULN if hepatic metastases were present), creatinine \<1.5 x ULN, absolute neutrophil count (ANC) \>1.5 x 10\^9/L, platelet count \>100 x 10\^9/L
Exclusion
- Patients with fewer than five years of disease-free survival from any other (non-GIST) malignancy except if the other malignancy was not currently clinically significant and did not require active intervention or if the other malignancy was a basal cell skin cancer or a cervical carcinoma in situ
- Patients with known brain metastases
- Evidence of any of the following disorders: Grade III/IV cardiac failure as defined by the New York Heart Association Criteria, severe concomitant disease, acute or known chronic liver disease (i.e. chronic active hepatitis, cirrhosis) or HIV infection
- Chemotherapy or other investigational therapy within four weeks prior to study entry (six weeks for nitrosourea or mitomycin-C) and/or radiotherapy to ≥25% of the bone marrow
- Inability to cooperate
- Major surgery within two weeks or exposure to other investigational agents within 28 days of entry into the study
- Other protocol-defined inclusion / exclusion criteria may have applied.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00237185
Start Date
June 1 2000
End Date
June 1 2013
Last Update
August 19 2014
Active Locations (5)
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1
Dana Farber Cancer Institute Dept of Sarcoma Oncology
Boston, Massachusetts, United States, 02115
2
Oregon Health Sciences University Dept. of Oregon Health Sci.
Portland, Oregon, United States, 97201
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
4
Novartis Investigative Site
Geelong, Victoria, Australia, 3220