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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00611793
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignancies
  • Refractory Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTK787/ZK222584 and Bevacizumab — DRUG
    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.

Study Details

PTK787/ZK222584 is an orally active inhibitor of VEGF-R tyrosine kinases. Bevacizumab is an intravenous humanized monoclonal antibody directed against vascular endothelial growth factor. By binding to VEGF, bevacizumab blocks VEGF-A receptor binding. Due to the different mechanisms of action and the non-overlapping toxicity profiles of the two agents, it is hoped that a combination regimen incorporating both compounds will produce increased activity without enhanced toxicity.

Key Dates

First listed
Feb 11, 2008
Start date
Oct 31, 2004
Status verified
Jan 2009
Primary completion
Jan 31, 2008
Completion
Jan 31, 2009

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    PTK787/ZK222584 and Bevacizumab

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Oncology, PLLCNashvilleTennessee37023-

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By research site
Tennessee Oncology, PLLC· Nashville, TN

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