CClinicalTrials.gg
CompletedNCT00389389Updated May 1, 2009

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

A Phase 1 interventional study of AZD4877 in Neoplasms, sponsored by AstraZeneca. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-01.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Neoplasms

Keywords

  • Advanced Solid Malignancies
  • Advanced solid tumors
  • Cancer
  • Phase I
  • Solid tumors
  • Solid malignancies
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells).
  • Serious heart conditions.
  • Poor liver or kidney function.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Interventions

  • DrugAZD4877

    intravenous infusion

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

3 sites
  • Research Site
    Denver, Colorado, United States
  • Research Site
    Nashville, Tennessee, United States
  • Research Site
    Houston, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00389389
Lead sponsor
AstraZeneca
First posted
Oct 18, 2006
Start date
Sep 2006
Primary completion
Aug 2008
Completion
Oct 2008
Last update
May 1, 2009

Study contacts

Judith Ochs, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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