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AZD1152 in Patients With Advanced Solid Malignancies

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 16, 2006
Last updated: April 21, 2017
Last verified: April 2017
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.

Condition Intervention Phase
Drug: AZD1152 part A
Drug: AZD1152 part B
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG) [ Time Frame: Throughout the study. Approximately 9 months for most patients. ]
    Safety and tolerability will be assessed through the incidence of adverse events. Adverse events will include significant findings on vital signs, clinical chemistry/haematology, coagulation parameters and electrocardiograms (ECGs).

Secondary Outcome Measures:
  • Assessment of pharmacodynamic biomarker changes [ Time Frame: Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).] ]
    Evaluation of AZD1152 activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to biomarkers of Aurora kinase activity.

Enrollment: 43
Actual Study Start Date: May 23, 2006
Study Completion Date: March 1, 2017
Primary Completion Date: June 6, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD1152
AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
Drug: AZD1152 part A
48-hour continuous intravenous infusion
Drug: AZD1152 part B
2-hour intravenous infusion


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological confirmation of a solid, malignant tumour
  • At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Exclusion Criteria:

  • Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug
  • Recent major surgery within 4 weeks prior to entry into the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00338182

United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
New York, New York, United States
Sponsors and Collaborators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00338182     History of Changes
Other Study ID Numbers: D1531C00002
Study First Received: June 16, 2006
Last Updated: April 21, 2017

Keywords provided by AstraZeneca:
Solid tumor processed this record on April 25, 2017