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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389389

Enrollment

Registered

2006-10-18

Start date

2006-09-30

Completion date

2008-10-31

Last updated

2009-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Advanced Solid Malignancies, Advanced solid tumors, Cancer, Phase I, Solid tumors, Solid malignancies

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

Interventions

DRUGAZD4877

intravenous infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026