AZD1152 in Patients With Advanced Solid Malignancies-Study 3

May 13, 2009 updated by: AstraZeneca

A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 7-Day Intravenous Infusion in Patients With Advanced Solid Malignancies

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological or cytological confirmation of a solid, malignant tumour

Exclusion Criteria:

  • Participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug
  • Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
  • Recent major surgery within 4 weeks prior to entry to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability
Time Frame: Assessed at each visit
Assessed at each visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: Assessed at predetermined timepoints after dose administration
Assessed at predetermined timepoints after dose administration
Effect on biomarkers
Time Frame: Assessed after treatment
Assessed after treatment
Anti-tumor activity
Time Frame: Assessed at the end of treatment
Assessed at the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: David Kerr, MD, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1531C00003
  • EudraCT: 2005-004244-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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