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AZD1152 in Patients With Advanced Solid Malignancies-Study 3

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ClinicalTrials.gov Identifier: NCT00497679
Recruitment Status : Terminated (Study is now terminated due to technical difficulties with administration of study drug in this patient population with this schedule)
First Posted : July 9, 2007
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Solid Tumours Drug: AZD1152 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2006
Study Completion Date : July 2007
Arms and Interventions

Intervention Details:
    Drug: AZD1152
    7-day continuous intravenous infusion

Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Assessed at each visit ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Assessed at predetermined timepoints after dose administration ]
  2. Effect on biomarkers [ Time Frame: Assessed after treatment ]
  3. Anti-tumor activity [ Time Frame: Assessed at the end of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00497679     History of Changes
Other Study ID Numbers: D1531C00003
EudraCT: 2005-004244-31
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
advanced solid tumours