MedTrace Logo

PTK 787 and Gleevec in Patients With AML, AMM, and CML-BP

NCT00088231 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2012-01-20

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe doses of PTK 787 (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is.

Conditions

  • Acute Myelogenous Leukemia
  • Agnogenic Myeloid Metaplasia
  • Chronic Myelogenous Leukemia

Interventions

DRUG

Imatinib Mesylate (Gleevec)

600 mg by mouth every day (for AML, CML-BP) for a 28 day cycle. 400 mg by mouth every day (for AMM) for a 28 day cycle.

DRUG

PTK 787 (vatalanib)

For 1 week prior to receipt of the study combination regimen, all patients will receive single agent PTK 787 at the dose specified for that dose level of the study combination regimen to allow stabilization of PTK 787 levels. Starting dose: 250 mg by mouth every day for a 28 day cycle.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00088231 on ClinicalTrials.gov