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
  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:


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
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: 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 July 22, 2014