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

AstraZeneca1 site in 1 country75 target enrollmentSeptember 2006

ConditionsNeoplasms

DrugsAZD4877

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neoplasms
Sponsor: AstraZeneca
Enrollment: 75
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

October 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.(Assessed after the first course of treatment)