AZD1152 in Patients With Advanced Solid Malignancies

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. Identifier: NCT00338182
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Tumors Drug: AZD1152 part A Drug: AZD1152 part B Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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 or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies
Actual Study Start Date : May 23, 2006
Actual Primary Completion Date : June 6, 2008
Actual Study Completion Date : March 1, 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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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

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 identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00338182     History of Changes
Other Study ID Numbers: D1531C00002
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by AstraZeneca:
Solid tumor