Part B of the study was terminated early due to a lack of enrollment.
A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma
Sponsor study identifier
interventional
44
1 country
3
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2008
Actual (reported)This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 7, 2007
Actual (reported)May 9, 2007
Actual (reported)December 2008
Actual (reported)To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
on a twice a week schedule for two weeks out of every three weeks
To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification
assessed after each course of treatment
Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma
Assessed during treatment and post treatment
intravenous infusion administered twice a week for 2 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Jeffrey Skolnik, MD
AstraZeneca
Lea Burke
AstraZeneca
First Submitted
May 7, 2007
First Posted
May 9, 2007
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2008
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
September 24, 2009
Record last verified: 2009-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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