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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
  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 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
Study Completion Date: July 2007
Intervention Details:
    Drug: AZD1152
    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
Manchester, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: David Kerr, MD University of Oxford
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00497679     History of Changes
Other Study ID Numbers: D1531C00003, EudraCT: 2005-004244-31
Study First Received: July 5, 2007
Last Updated: May 13, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
advanced solid tumours

ClinicalTrials.gov processed this record on May 22, 2013