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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014