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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00389389

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 ] [ 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
Estimated Study Completion Date:	September 2008

Intervention Details:

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

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

Study ID Numbers:	D2782C00001
Study First Received:	October 17, 2006
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00389389
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 January 16, 2009