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OpenTrials
Completed

NCT Number: NCT00338182

AZD1152 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.

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Key information

Conditions

Tumors Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1152 part A

Drug

48-hour continuous intravenous infusion

AZD1152 part B

Drug

2-hour intravenous infusion

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2017
First posted
Jun 20, 2006
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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