Overview

This trial is active, not recruiting.

Condition tumors
Treatments azd1152 part a, azd1152 part b
Phase phase 1
Sponsor AstraZeneca
Start date May 2006
End date June 2008
Trial size 43 participants
Trial identifier NCT00338182, D1531C00002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
azd1152 part a
48-hour continuous intravenous infusion
azd1152 part b
2-hour intravenous infusion

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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).]

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.