NCT00497679TerminatedPhase 1
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 7-Day Intravenous Infusion in Patients With Advanced Solid Malignancies
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- AstraZeneca
- Enrollment
- 45
- Locations
- 3
- Primary Endpoint
- Safety and Tolerability
Study Overview
Brief Summary
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological or cytological confirmation of a solid, malignant tumour
Exclusion Criteria
- •Participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug
- •Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
- •Recent major surgery within 4 weeks prior to entry to the study
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: Assessed at each visit
Secondary Outcomes
- Pharmacokinetics(Assessed at predetermined timepoints after dose administration)
- Effect on biomarkers(Assessed after treatment)
- Anti-tumor activity(Assessed at the end of treatment)
Investigators
Study Sites (3)
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