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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00497731
First received: July 5, 2007
Last updated: June 19, 2009
Last verified: June 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 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
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 2 Hour Intravenous Infusion on Two Dose Schedules 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 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

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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497731

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

No publications provided

ClinicalTrials.gov Identifier: NCT00497731     History of Changes
Other Study ID Numbers: D1531C00001
Study First Received: July 5, 2007
Last Updated: June 19, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
Advanced solid tumors

ClinicalTrials.gov processed this record on June 18, 2013