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AZD1152 in Patients With Advanced Solid Malignancies-Study 1

This study has been terminated.
(Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497731
First Posted: July 9, 2007
Last Update Posted: June 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.

Condition Intervention Phase
Solid Tumors Drug: AZD1152 Phase 1

Study Type: Interventional
Study Design: 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 2 Hour Intravenous Infusion on Two Dose Schedules 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 after treatment ]

Estimated Enrollment: 70
Study Start Date: May 2005
Estimated Study Completion Date: April 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD1152
    2-hour continuous intravenous infusion
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  • At least measurable or non measurable site of disease as defined by modified RECIST criteria.

Exclusion Criteria:

  • Participation in an investigational drug study within 30 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): NCT00497731


Locations
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jan Schellens, MD NKI
  More Information

ClinicalTrials.gov Identifier: NCT00497731     History of Changes
Other Study ID Numbers: D1531C00001
First Submitted: July 5, 2007
First Posted: July 9, 2007
Last Update Posted: June 22, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Advanced solid tumors