Protein Tyrosine Kinases (PTK) in Multiple Myeloma

December 20, 2007 updated by: Dana-Farber Cancer Institute

Phase II Study of PTK787/ZK222584 in Multiple Myeloma

The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.

Measurement of vital signs will be done weekly during the first month of treatment.

Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.

Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years of age.
  • Confirmed diagnosis of active progressive multiple myeloma
  • History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
  • Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count (ANC) > 1,500 mm3
  • Platelets > 100,000 mm3
  • Serum creatinine < 1.5 upper limit of normal (ULN)
  • Serum bilirubin < 1.5 ULN
  • AST/AGOT and ALT/SGPT < 3.0 ULN
  • Life expectancy > 12 weeks

Exclusion Criteria:

  • Chemotherapy < 3 weeks prior to registration.
  • Biologic or immunotherapy < 2 weeks prior to registration
  • Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to registration.
  • History or presence of central nervous system (CNS) disease
  • History of leukemia
  • History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin
  • Major surgery < 4 weeks prior to registration
  • Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Pleural effusion or ascites that cause respiratory compromise
  • Female patients that are pregnant or breast feeding
  • Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen
  • Unstable angina pectoris
  • Symptomatic congestive heart failure
  • Myocardial infarction < 6 months prior to registration
  • Serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
  • Active or uncontrolled infection
  • Acute or chronic liver disease
  • Impairment of gastrointestinal (GI) function or GI disease
  • Confirmed HIV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma

Secondary Outcome Measures

Outcome Measure
To evaluate the progression free survival of patients treated with PTK
to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Novartis
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Nikhil Munshi, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 20, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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