AZD1152 in Patients With Advanced Solid Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tumors

Intervention / Treatment
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* Drug: AZD1152 part A
* Drug: AZD1152 part B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1152<br>AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment) | Drug: AZD1152 part A<br>* 48-hour continuous intravenous infusion<br>Drug: AZD1152 part B<br>* 2-hour intravenous infusion<br>|

What is the study measuring?
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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).] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor