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Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389389
First Posted: October 18, 2006
Last Update Posted: May 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
October 17, 2006
October 18, 2006
May 1, 2009
September 2006
August 2008   (Final data collection date for primary outcome measure)
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. [ Time Frame: assessed at each treatment ]
Not Provided
Complete list of historical versions of study NCT00389389 on ClinicalTrials.gov Archive Site
Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment. [ Time Frame: Assessed after the first course of treatment ]
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Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors
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
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: AZD4877
intravenous infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
October 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00389389
D2782C00001
No
Not Provided
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AstraZeneca
Not Provided
Study Director: Judith Ochs, MD AstraZeneca
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP