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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389389
• Other study ID #: D2782C00001
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2006
• Last updated: April 30, 2009
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• AZD4877
intravenous infusion

Locations

Country	Name	City	State
United States	Research Site	Denver	Colorado
United States	Research Site	Houston	Texas
United States	Research Site	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.		Assessed after the first course of treatment	No