45
Participants
Start Date
July 31, 2004
Primary Completion Date
January 31, 2008
Study Completion Date
April 30, 2011
Imatinib and PTK/ZK222584
Imatinib and PTK/ZK will each be administered orally daily. Two dose levels of imatinib (400 mg and 600 mg) will be tested with 4 dose levels of PTK/ZK (250 mg, 500 mg, 750 mg, and 1000 mg). 3 patients will be accrued at each individual dose level. If dose-limiting toxicities are reported in ≤ 1/3 patients, the dose level will be expanded to 6 patients. If dose-limiting toxicities are reported in \< 2/6 patients, then dose escalation will continue. If ≥ 2/6 patients experience dose-limiting toxicity, the next lower dose will be considered the maximum tolerated dose and will be expanded to a total of 12 patients. There will be no intrapatient dose escalations. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered.
Tennessee Oncology, PLLC, Nashville
Collaborators (1)
Novartis
INDUSTRY
SCRI Development Innovations, LLC
OTHER