AZD1152 in Patients With Advanced Solid Malignancies-Study 3

This study has been terminated.

(Study is now terminated due to technical difficulties with administration of study drug in this patient population with this schedule)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00497679

First received: July 5, 2007

Last updated: May 13, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2007

Last Updated Date

May 13, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Safety and Tolerability [ Time Frame: Assessed at each visit ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00497679 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

AZD1152 in Patients With Advanced Solid Malignancies-Study 3

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Solid Tumours

Intervention ^ICMJE

Drug: AZD1152

7-day continuous intravenous infusion

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00497679

Other Study ID Numbers ^ICMJE

D1531C00003, EudraCT: 2005-004244-31

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Kerr, MD

University of Oxford

Information Provided By

AstraZeneca

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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