MedTrace Logo

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

NCT00611689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-02-04

No results posted yet for this study

Summary

In this phase I study, the investigators will determine the maximum tolerated doses of imatinib and PTK/ZK administered in two different dose schedules. Due to the different mechanisms of action and the minimally-overlapping toxicity profiles of these two novel oral agents, it is hoped that a combination regimen incorporating both compounds will produce increased activity without enhanced toxicity. After completion of this phase I study, the investigators propose a follow-up phase II study in patients with previously treated metastatic renal cell cancer - where VEGF and PDGF appear to play important roles in the malignant phenotype - to determine the antitumor efficacy of the recommended dose of this combination regimen.

Conditions

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • David Spigel, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2008-01-31
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611689 on ClinicalTrials.gov