Solid Tumors Clinical Trial
Official title:
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules 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 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.
Status | Terminated |
Enrollment | 70 |
Est. completion date | April 2009 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological or cytological confirmation of a solid, malignant tumour - At least measurable or non measurable site of disease as defined by modified RECIST criteria. Exclusion Criteria: - Participation in an investigational drug study within 30 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Research Site | Amsterdam | |
Netherlands | Research Site | Utrecht |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability | Assessed at each visit | ||
Secondary | Pharmacokinetics | Assessed at predetermined timepoints after dose administration | ||
Secondary | Effect on biomarkers | Assessed after treatment | ||
Secondary | Anti-tumor activity | Assessed after treatment |
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