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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00389389
First received: October 17, 2006
Last updated: April 30, 2009
Last verified: April 2009
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00389389

Locations
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
AstraZeneca
Investigators
Study Director: Judith Ochs, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389389     History of Changes
Other Study ID Numbers: D2782C00001
Study First Received: October 17, 2006
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced Solid Malignancies
Advanced solid tumors
Cancer
Phase I
Solid tumors
Solid malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014