AZD1152 in Patients With Advanced Solid Malignancies-Study 3 - Full Text View

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 )

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00497679

Purpose

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.

Condition	Intervention	Phase
Solid Tumours	Drug: AZD1152	Phase I

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	45
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2009

Intervention Details:

7-day continuous intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497679

Locations


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

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	David Kerr, MD	University of Oxford

More Information

Study ID Numbers:	D1531C00003, EudraCT: 2005-004244-31
First Received:	July 5, 2007
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00497679
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

advanced solid tumours

ClinicalTrials.gov processed this record on October 06, 2008