NCT00389389

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

1.9 years

First QC Date

October 17, 2006

Last Update Submit

April 30, 2009

Conditions

Neoplasms

Keywords

Advanced Solid MalignanciesAdvanced solid tumorsCancerPhase ISolid tumorsSolid malignancies

Outcome Measures

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.

    assessed at each treatment

Secondary Outcomes (1)

  • Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.

    Assessed after the first course of treatment

Interventions

AZD4877DRUG

intravenous infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
  • Relatively good overall health other than your cancer.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Denver, Colorado, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Houston, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

N-(3-aminopropyl)-N-(1-(5-benzyl-3-methyl-4-oxo-(1,2)thiazolo(5,4-d)pyrimidin-6-yl)-2-methylpropyl)-4-methylbenzamide

Study Officials

  • Judith Ochs, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2008

Study Completion

October 1, 2008

Last Updated

May 1, 2009

Record last verified: 2009-04

Locations

US(3)