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

Phase 1

Completed

• Conditions: Neoplasms

• Registration Number: NCT00389389
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-18
• Primary Completion: 2008-08
• Study Completion: 2008-10
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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Exclusion Criteria

• Poor bone marrow function (not producing enough blood cells).
• Serious heart conditions.
• Poor liver or kidney function.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.	Assessed after the first course of treatment

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States