Imatinib and PTK787/ZK222584 in Refractory and/or Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

January 31, 2008

Study Completion Date

April 30, 2011

Conditions
Refractory MalignancySolid Tumors
Interventions
DRUG

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.

Trial Locations (1)

37023

Tennessee Oncology, PLLC, Nashville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER