AZD1152 in Patients With Advanced Solid Malignancies

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

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.

Study Overview

• Status: Completed
• Conditions: Tumors
• Intervention / Treatment: Drug: AZD1152 part A; Drug: AZD1152 part B

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • Research Site
  • New York
    • New York, New York, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)	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).	Throughout the study. Approximately 9 months for most patients.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pharmacodynamic biomarker changes	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.	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).]

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Related Info
• CSR-D1531C00002.pdf

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2006
• Primary Completion (Actual): June 6, 2008
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 16, 2006
• First Submitted That Met QC Criteria: June 16, 2006
• First Posted (Estimate): June 20, 2006

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Solid tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: D1531C00002