Back to resultsPhase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies
Primary Purpose
Lymphoma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD4877
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Phase I, cancer, lymphoma, leukemia, myeloma, AML, ALL, NHL, MM
Eligibility Criteria
Inclusion Criteria:
- Patients with AML, a certain type of ALL, NHL and MM
- certain types of cancer of the lymph nodes
- certain types of leukemias (blood cancers)
- disease has or will fail with other treatments
- 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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00460460
Brief Title
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies
Official Title
A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to low enrollment
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Phase I, cancer, lymphoma, leukemia, myeloma, AML, ALL, NHL, MM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD4877
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with AML, a certain type of ALL, NHL and MM
certain types of cancer of the lymph nodes
certain types of leukemias (blood cancers)
disease has or will fail with other treatments
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
Judith Ochs, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies
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