Study Stopped
Part B of the study was terminated early due to a lack of enrollment.
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
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
1 other identifier
interventional
44
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 lymphoma
Started Apr 2007
Shorter than P25 for phase_1 lymphoma
3 active sites
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
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 9, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedSeptember 24, 2009
September 1, 2009
May 7, 2007
September 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Interventions
intravenous infusion administered twice a week for 2 weeks
Eligibility Criteria
You may qualify if:
- Part A: Advanced solid tumors (including lymphoma without bone marrow involvement) for which standard treatment doesn't exist or is no longer effective.
- Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has relapsed.
- Relatively good overall health other than your cancer
You may not qualify if:
- Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeffrey Skolnik, MD
AstraZeneca
- STUDY CHAIR
Lea Burke
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 9, 2007
Study Start
April 1, 2007
Study Completion
December 1, 2008
Last Updated
September 24, 2009
Record last verified: 2009-09