Status:
COMPLETED
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in th...
Eligibility Criteria
Inclusion
- Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Other inclusion applies.
Exclusion
- Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.
- Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
- Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for \>= 2 weeks before day 1).
- Other exclusion applies.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00195260
Start Date
October 1 2004
End Date
November 1 2007
Last Update
February 11 2013
Active Locations (19)
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1
Pfizer Investigational Site
Birmington, Alabama, United States, 35233
2
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
3
Pfizer Investigational Site
Los Angeles, California, United States, 90033
4
Pfizer Investigational Site
Tampa, Florida, United States, 33612