AZD1152 in Patients With Advanced Solid Malignancies

AstraZeneca43 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumors

Interventions

AZD1152 part ADRUG

48-hour continuous intravenous infusion

AZD1152 part BDRUG

2-hour intravenous infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Outcomes

Primary Outcomes

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).

Time frame: Throughout the study. Approximately 9 months for most patients.

Secondary Outcomes

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.

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).]

Data from ClinicalTrials.gov

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