Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00389389
Collaborator
(none)
75
3
25
25
1
Study Details
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 experiences by patients that receive AZD4877 on a weekly basis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
75 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies
Study Start Date
:
Sep 1, 2006
Actual Primary Completion Date
:
Aug 1, 2008
Actual Study Completion Date
:
Oct 1, 2008
Outcome Measures
Primary Outcome Measures
- To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment. [assessed at each treatment]
Secondary Outcome Measures
- Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment. [Assessed after the first course of treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Denver | Colorado | United States | |
| 2 | Research Site | Nashville | Tennessee | United States | |
| 3 | Research Site | Houston | Texas | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Judith Ochs, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00389389
Other Study ID Numbers:
- D2782C00001
First Posted:
Oct 18, 2006
Last Update Posted:
May 1, 2009
Last Verified:
Apr 1, 2009
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