PTK787/ZK222584 With Bevacizumab in Patients With Refractory and/or Advanced Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2009

Conditions
Refractory MalignancyAdvanced Malignancies
Interventions
DRUG

PTK787/ZK222584 and Bevacizumab

PTK787/ZK222584 will be administered as a single agent orally on days 1-14 of cycle 1. The day 14 dose of PTK787/ZK222584 will be administered in the outpatient clinic and PK samples will be obtained. On Day 15 the patient will receive the initial dose of IV bevacizumab and PTK787/ZK222584. Bevacizumab will be repeated at 2 week intervals in patients with stable disease or better for four cycles of treatment (16 weeks). After four treatment cycles, only patients with a PR or CR will continue treatment with PTK787/ZK222584 and bevacizumab. Patients with stable disease may continue single agent PTK787/ZK22258 from cycle 5 onward. Protocol treatment will continue until disease progression or intolerable toxicity warrants drug discontinuation.

Trial Locations (1)

37023

Tennessee Oncology, PLLC, Nashville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT00611793 - PTK787/ZK222584 With Bevacizumab in Patients With Refractory and/or Advanced Malignancies | Biotech Hunter | Biotech Hunter