AZD1152 in Patients With Advanced Solid Malignancies
This trial is active, not recruiting.
|Treatments||azd1152 part a, azd1152 part b|
|Start date||May 2006|
|End date||June 2008|
|Trial size||43 participants|
|Trial identifier||NCT00338182, D1531C00002|
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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
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.
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).]
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
|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|
Call for more information