Back to resultsPhase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
Primary Purpose
Lymphoma, NHL, Non-Hodgkin Lymphoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD4877
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Phase I, AZD4877, Lymphoma, B-cell non-Hodgkin lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471367
Brief Title
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
Part B of the study was terminated early due to a lack of enrollment.
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, NHL, Non-Hodgkin Lymphoma
Keywords
Phase I, AZD4877, Lymphoma, B-cell non-Hodgkin lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD4877
Intervention Description
intravenous infusion administered twice a week for 2 weeks
Primary Outcome Measure Information:
Title
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
Time Frame
on a twice a week schedule for two weeks out of every three weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
assessed after each course of treatment
Title
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
Time Frame
Assessed during treatment and post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Skolnik, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lea Burke
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
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