NCT00165347

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

Enrollment Period

2.8 years

First QC Date

September 9, 2005

Last Update Submit

December 20, 2007

Conditions

Multiple Myeloma

Keywords

Multiple myelomaPTKRelapsed multiple myelomaRefractory Multiple myelomaMyeloma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • To evaluate the progression free survival of patients treated with PTK

  • to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma

Interventions

PTK787/ZK222584DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Nikhil Munshi, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(1)