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AZD1152 in Patients With Advanced Solid Malignancies-Study 1

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ClinicalTrials.gov Identifier: NCT00497731
Recruitment Status : Terminated (Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.)
First Posted : July 9, 2007
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: AZD1152 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies
Study Start Date : May 2005
Primary Completion Date : June 2008
Estimated Study Completion Date : April 2009

Intervention Details:
    Drug: AZD1152
    2-hour continuous intravenous infusion


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 after treatment ]


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
  • 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

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

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

Keywords provided by AstraZeneca:
Advanced solid tumors