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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 17, 2006
Last updated: April 30, 2009
Last verified: April 2009
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 Intervention Phase
Neoplasms Drug: AZD4877 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

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. [ Time Frame: assessed at each treatment ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD4877
    intravenous infusion

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00389389

United States, Colorado
Research Site
Denver, Colorado, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
Sponsors and Collaborators
Study Director: Judith Ochs, MD AstraZeneca
  More Information Identifier: NCT00389389     History of Changes
Other Study ID Numbers: D2782C00001
Study First Received: October 17, 2006
Last Updated: April 30, 2009

Keywords provided by AstraZeneca:
Advanced Solid Malignancies
Advanced solid tumors
Phase I
Solid tumors
Solid malignancies processed this record on August 18, 2017