Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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 this subject population.

Key facts

Study ID

NCT00195260

Run by

Pfizer

People needed

151

Starts

2004-10-01

Expected to finish

2007-11-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Birmington, Alabama, United States
• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Indianpolis, Indiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Lansing, Michigan, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — UNC Chapel Hill, North Carolina, United States
• Pfizer Investigational Site — UNC Chapel Hill, North Carolina, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Tyler, Texas, United States
• Pfizer Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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