AZD1152 in Patients With Advanced Solid Malignancies

Phase 1

Completed

• Conditions: Tumors
• Interventions: Drug: AZD1152 part A; Drug: AZD1152 part B

• Registration Number: NCT00338182
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-05-23
• Study First Submitted: 2006-06-16
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Primary Completion: 2008-06-06
• Study Completion: 2017-03-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD1152	AZD1152 part B	AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
AZD1152	AZD1152 part A	AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)	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

Name	Time	Method
Assessment of pharmacodynamic biomarker changes	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 New York, New York, United States