Protein Tyrosine Kinases (PTK) in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Phase II Study of PTK787/ZK222584 in Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165347
• Other study ID #: 03-257
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 20, 2007
• Start date: December 2003
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• PTK787/ZK222584

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
Secondary	To evaluate the progression free survival of patients treated with PTK
Secondary	to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma